Getting to answers with clinical trials: Being bold

Prof. Thomas ZellerDepartment AngiologyUniversity Heart-Center Freiburg - Bad KrozingenBad Krozingen , Germany

Faculty Disclosure

For the 12 months preceding this presentation, I disclose the following types of financial relationships:

• Honoraria received from: Abbott Vascular, Angioslide, Bard Peripheral Vascular, Veryan, Biotronik, Boston Scientific Corp., Cook Medical, Cordis Corp., Covidien, Gore & Associates, Medtronic, Spectranetics, Straub Medical, TriReme, VIVA Physicians

• Consulted for: Abbott Vascular, Bard Peripheral Vascular, Boston Scientific Corp., Cook Medical, Gore & Associates, Medtronic, Spectranetics, ReCor

• Research, clinical trial, or drug study funds received from:480 biomedical, Bard Peripheral Vascular, Veryan, Biotronik, Cook Medical, Cordis Corp., Covidien, Gore & Associates, Abbott Vascular -DEV Technologies, Inc., Medtronic, Spectranetics, Terumo, TriReme, Volcano

• Thomas Zeller, MD

Landscape of PAD treatment

• Treatments for PAD are growing and changing – PTA and Bare Metal Stents are used most often – Leave nothing behind can include multiple strategies

• Atherectomy• PTA• DCB

• Each RCT is unique• RCT are not equal to the Registry

– Registries are often not as rigorous as RCTs• Core lab• DSMB/CEC• Patient population

• Data are needed to determine the best path forward

BMS, DES, DCB, Atherectomy

Drug Eluting Stents - Peripheral

SFA BTK

Zilver PTXCook Medical

Eluvia™ DESBoston Scientific

Promus Element PlusBTK

Boston Scientific

Xience Prime BTKAbbott Vascular

Product Image

CE Mark/US Approval

CE US CE US CE US CE US

No

Not indicated for BTK in

US

No

Stent Platform Zilver Flex Innova Promus Premier

Material Nitinol Nitinol Platinum Chromium Alloy Cobalt Chromium

Polymer NoneBiostable Fluorinated

Polymer MatrixBiostable Fluorinated

Polymer MatrixBiostable Fluorinated

Polymer Matrix

Drug Paclitaxel Paclitaxel Everolimus Everolimus

Deployment Self-expandable Self-expandable Balloon Expandable Balloon Expandable

SizesDiameter Length Diameter Length Diameter Length Diameter Length

6-8mm 40-120mm 6-7mm 40-150mm 2.25-4mm 12-38mm 2.5-4mm 28-38mm

www.abbottvascular.com/int/products/peripheral-intervention/xience-prime-btk.html#ordering-information.

www.medicalexpo.com/prod/abbott-vascular/peripheral-stents-drug-eluting-90137-572891.html

Cook Medical (2014). Zilver PTX Drug-Eluting Peripheral Stent Instructions for Use

http://zilverptx.cookmedical.com/us/index.html#

Drug-Coated Balloons - Peripheral

IN.PACT Admiral Medtronic

LutonixTM

BardStellarex™

SpectraneticsRanger™

Boston Scientific

Product Image

Paclitaxel Dose 3.5 µg/mm2 2 µg/mm2 2 μg/mm2 2 µg/mm2

Coating TechnologyFreePac™ hydrophilic coating

(excipient: urea)Proprietary hydrophilicnonpolymeric carrier

EnduraCoat™ coating(excipient: Poly-ethylene

Glycol)

TransPax coating(excipient: Citrate ester)

Guidewire Compatibility

0.035 OTW 0.035 OTW 0.035 OTW 0.14/0.18

MatrixSFA: 4-7 mm; 40-120 mm

BTK: Recalled

SFA: 4-6 mm; 40-100 mm

SFA: 4-6 mm;40-120 mm

SFA: 4-8 mm;30-100 mm

BTK: 2-4 mm; up to 150 mm

CE Mark

FDA Approval

Atherectomy Devices

Jetstream™

Atherectomy System

(Boston Scientific)

Diamondback 360™,

Stealth 360™

Atherectomy System

(Cardiovascular

Systems, Inc)

SilverHawk™,

TurboHawk™

Plaque Excision System

(Covidien)

Turbo-Elite™

Laser Atherectomy

Catheter

(Spectranetics)

Product Image

Front-Cutting ()

Differential Cutting NA

Active Aspiration

Concentric Lumens

Lesion Morphology:

Calcium 2,3 4 (large vessel only)1 () 1

Soft/Fibrotic Plaque 2 5 1

Thrombus 1 contraindicated1 1

In-stent restenosis 6 (), not approved 7

1. Instructions for Use/product website. 2. Zeller T, et al. J Endovasc Ther. 2009;16(6):653-662. 3. Maehara A, et al. EuroIntervention. 2015 19;11(1):96-103. 4. Shammas N, et al. J

Endovascular Ther, 2012; 19:480-488. 5. McKinsey JF, et al. JACC Cardiovasc Interv. 2014 ;7(8):923-33. 6. Shammas NW, et al. J Endovasc Ther. 2016 ;23(2):339-46. 7. Dippel

EJ,et al. JACC Cardiovasc Interv. 2015 ;8(1 Pt A):92-101.

Outcomes for BMS, DES, DCB studies

Shishebor M, Jaff M. Circulation 2016.

Device Rutherford Class, % Lesion Length Patency, %II III IV mm Year 1 Year 2 Year 3 Year 4 Year 5

Wire interwoven Nitinolstents

37.5 57.2 5.3 78.1 86.3 NA NA NA NA

Drug-elutingstents

90.3 8.9 66.4 83.1 76.3 71.5 67.4 66.4

Covered stent59,60 18 68 3 189.8

7378

69.4 24.2 NA NA

Drug-coated balloons

Lutonix 29.4 62.7 7.9 62.8 65.2 58.6 NA NA NA

In.PACT 37.3 57.3 5.4 89.4 83.2 78.9 NA NA NA

Outcomes for Atherectomy studies

Device Name*Mechanism of

ActionStudy

No. of Patients/Lesions

Procedural Success Rate

Procedural Complication Rate

Diamondback 360 Orbital

CALCIUM 360°79 50/6493.1% in OA with PTA vs 82.4% in PTA alone

Bailout stenting 6.9% vs 14.3% in

PTA alone

OASIS81 124/201 90.1% 2.5%

COMPLIANCE 36082 50/65

Residual stenosis ≤30% w/o stenting: 86.8% in

OA vs 18.5% in PTA

Stenting in 5.3% in the OA vs 77.8%

CONFIRM series83 3,135/4,766

OA decreased preprocedural stenosis from an avg of 88% to

35%

Stenting in <5.7%

Excimer Laser Photoablative

LACI73 145/155

Procedural success (<50% residual

stenosis) in 85% of the limbs

Procedural complication in 12%

of the limbs

EXCITE ISR74 25093.5% in ELA + PTA vs

82.7% in PTA alone

Bailout stenting of 4.1% in ELA+PTA vs 11.1% in PTA alone

JetstreamRotational / Aspirational

TRUE78 18Increase in mean

luminal volume of 64.3 mm3

0%

Silverhawk/Turbohawk

Excisional / Directional

DEFINITIVE LE75 799/1022 89%Bailout stenting

3.2%

Shishebor M, Jaff M. Circulation 2016.

Peripheral InterventionHistorical Patient Populations

* Transatlantic Inter-Society Consensus (TASC ) II Lesion Classification (Type A, B, C, D ) for Peripheral Arterial Disease

Simple Complex

A* B C D

POBA

DCB

Stents (Bare, Covered, DES)

Surgery

Longer, more calcium

• DEFINITIVE AR: directional atherectomy + DCB vs DCB alone

• Adjunctive atherectomy may improve procedural and clinical outcomes following DCB treatment of the SFA and/or popliteal artery, particularly for longer or severely calcified lesions

Adjunctive treatment? DCB+Atherectomy: Clinical Evidence

Zeller, VIVA 2014.

*Technical success: Defined as ≤ 30% residual stenosis following the protocol-defined treatment at the target lesion as determined

by the Angiographic Core Laboratory. DCB, drug-coated balloon; DUS, duplex ultrasound; SFA, superficial femoral artery

DCB Ath + DCB

Technical Success* 64.2% 89.6%

Bail-out Stent 3.7% 0%

Flow-limiting Dissection 19% 2%

Procedural Results

86%

63%

90%97%

70%

93%

0%

20%

40%

60%

80%

100%

Lesions >10 cm Severely Calcified All patients

DCB DCB + Ather

n=23 n=8 n=27 n=54 n=48n=31

Duplex Ultrasound Patency at 12-months

Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: results from the IN.PACT DEEP randomized trial• Multicenter RCT• 358 CLI patients• Randomized DEB vs PTA 2:1• Primary endpoints

– Clinically driven lesion TLR– Late lumen loss– 6 months composite mortality, major amp, CD-TLR

Zeller T , J Am Coll Cardiol 2014

InPact Deep RCT

DEB PTA

Clinically Driven TLR 9.2% 13.1%

Late Lumen Loss 0.61 ± 0.78 0.62 ± 0.78

Major Amputation 8.8% 3.6% (P=0.08)

Primary Safety(mortality, major amputation, CD TLR)

17.7% 15.8%

Below the kneeDCB vs PTA

Systematic Review of infrapopliteal DES: A meta-analysis of randomized controlled trials

• 3 RCTs with 501 patients– Achilles: DES vs PTA in CLI & IC, n=200

– Destiny: DES vs BMS in CLI, n=140

– Yukon-BTX: DES vs BMS in CLI & IC, n=161

• Relatively short and focal infrapopliteal lesions

Katsanos K et al, Cardiovasc Intervent Radiol 2013

Below the kneeDES vs PTA/BMS

InfraPop: Meta-Analysis of RCT

Results at 1 year DES PTA/BMS P=

Primary Patency 80.0% 58.8% <0.0001

Rutherford class improvement 79.0% 69.6% 0.045

Wound healing 76.8% 59.7% 0.04

TLR 9.9% 22.0% 0.001

Event-free survival 72.2% 57.3% <0.0001

Survival 85.5% 86.6% 0.75

Amputation 6.4% 10.8% 0.11

PADI CLI: PTA±BMS vs DES for infrapopliteal lesions

• Multi-center randomized two-arm study• 136 patients with 144 limbs

– CLI, Rutherford 4-6– De novo stenoses or occlusions below knee

joint– Vessel diameter 2-6 mm, length ≤ 90 mm

• PTA±BMS or paclitaxel-DES (Taxus Liberté)• Heparin, Aspirin, Clopidogrel

Overhagen et al. Circ Cardiovasc Interv 2016

Below the knee DES vs PTA/BMS

Putting it all together…

Katsanos K: J Vasc Surg 2014;59;1123-1133

Baseline risk adjusted random effects mixed treatment comparison

Clinical results of Drug-Eluting Technologies

Network meta-analysis of RCTs of endovascular treatmentPOBA vs. DCB vs. DES vs. BMS vs. Covered stents

Results:

TLR lowest with paclitaxel-coated balloon and paclitaxel-eluting stent

Vascular restenosis lowest with paclitaxel-eluting stent and paclitaxel-coated balloon

Gaps in the data?

• DCB in Complex Lesions

• DCB vs DES

• Atherectomy + DCB

• DCB vs DCB

• DES vs DES

• Primary patency or TLR? Relavance?

• BTK? We need more data

Clinical Study DataImportant Characteristics and Outcomes

Clinical CharacteristicsAngiographic

CharacteristicsOutcomes

Demographics (age, sex, socioeconomic class)

Lesion location, lengthPatency (primary, assisted primary,

secondary)

Diabetes mellitus CalcificationClinically driven target lesion

revascularization

Chronic kidney disease Number of runoff 6-minue walk test

Rutherford class Stenosis versus occlusion Quality-of-life metrics

Ankle brachial index De novo versus restenosis Amputation free survival

Toe brachial index Major adverse limb events

Comorbid coronary, cerebrovascular conditions

Time to wound healing

Wound location, size, and depth Time to ambulation

Soft tissue/bone infection Hospital length of stay

Readmission

Total medical expense

Shishebor M, Jaff M. Circulation 2016.

Clinical StudiesMeaningful Endpoints

Late Lumen Loss

Important to:

•Physicians

•Regulatory agencies

Primary Patency

Important to:

•Physicians

•Regulatory agencies

Freedom from TLR

Important to:

•Physicians

•Patients

•Payers

•Regulatory agencies???

Patient Outcomes

Important to:

•Physicians

•Patients

•Payers

•Regulatory agencies

Randomized Controlled Trials Real world studies

Being Bold, BSC approach to finding the answers

Prospective, multicenter, single-arm, open label

n= 57 (2yr follow-up complete)

Prospective, multicenter, RCT 2:1 (Eluvia : Zilver PTX)

n = 485 (Enrolling)

Prospective, multicenter, RCT 2:1 (Eluvia : BMS)n = 750 (Enrolling)

Prospective, multicenter, single-arm, open labeln = 500 (Enrolling)

Prospective, multicenter, randomizedn = 105

Prospective, multicenter, RCT 3:1 (Ranger : POBA)• n = 376

Prospective, multicenter, single-arm• n = 123

IMPERIAL(DES)

MAJESTIC(DES)

EMINENT(DES/BMS)

REGAL(DES)

Ranger II(DCB)

Boston Scientific Drug ElutionClinical Program

Ranger FIM(DCB)

Ranger China(DCB)

Boston Scientific Global Pivotal StudyIMPERIAL Trial

Clinical Study Overview: IMPERIAL

Title A randomIzed trial coMParing the ELUVIA dRug-elutIng stent versus Zilver PTX stent for treatment of superficiAL femoral and/or proximal popliteal arteries

Primary Investigators Global: William A. Gray, MD

European: Prof. Dr. med Stefan Müller-Hülsbeck

Objective To evaluate the safety and effectiveness of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 140 mm in length.

Study Design The trial consists of the following:

• A prospective, multicenter, 2:1 randomized (ELUVIA vs Zilver PTX), controlled, single-blind, non-inferiority trial (RCT)

• A concurrent, non-blinded, single-arm, pharmacokinetic(PK) sub-study

• A concurrent, non-blinded, non-randomized, single arm Long Lesion sub-study (lesions 140mm-190mm in length treated with ELUVIA)

Subjects • 465 subjects treated with ELUVIA (N=310) or Zilver PTX (N=155)

• 12-20 subjects treated with ELUVIA in the PK sub-study

• 50 subjects treated with ELUVIA in the Long Lesion sub-study

Investigational Centers Up to 75 centers in US, Canada, New Zealand, Belgium, Germany, Austria, and Japan

Boston Scientific Global Pivotal StudyIMPERIAL Trial

Clinical Study Overview: IMPERIAL

Primary Efficacy Endpoint

Primary vessel patency as assessed by duplex ultrasound (DUS) at 12 months post-procedure and adjudicated by an independent core laboratory.

Primary Safety Endpoint

Major Adverse Event (MAE) rate defined as• All cause death through 1 month• Target limb major amputation through 12 months• Target lesion revascularization (TLR) through 12 months

Study Stents Zilver PTX Eluvia

Medicinal Substance Paclitaxel Paclitaxel

Coating Design No carrier PROMUS Polymer

Drug/Total Dose3µg/mm2

8 x 120mm = 1112 µg0.167µg/mm2

7 x 150mm = 517 µg

Size Matrix6-8mm

40-120mm 6 & 7mm

40-150 mm

SEM Image 100x

Boston Scientific Global Pivotal StudyRANGER II SFA

Clinical Study Overview: RANGER II SFA

Title A 3:1 Randomized Trial Comparing the Boston Scientific RANGER Paclitaxel Coated Balloon vs Standard Balloon Angioplasty for the Treatment of Superficial Femoral Arteries (SFA) and Proximal Popliteal Arteries (PPA)

Primary Investigators Global: Prof. Thomas Zeller, MD - Germany

National: Ravish Sachar, MD, FACC – United States

Objective To evaluate the safety and effectiveness of the RANGER™ Paclitaxel Coated Balloon for treating lesions located in the SFA and PPA

Study Design The trial consists of the following:• Prospective, multicenter, single-blind, superiority, RCT 3:1 (RANGER DCB : Standard PTA)• A concurrent, non-blinded, single-arm, pharmacokinetic(PK) sub-study

Subjects 396 patients• At least 376 patients into the randomized arm• 12 to 20 subjects in the non-randomized PK Sub-study

Investigational Centers

Up to 70 study centers in Canada, Europe (Austria, Belgium, Germany, Poland), Japan, New Zealand, and U.S.

Primary EfficacyEndpoint

Primary Patency of lesion• Determined by DUS and absence of clinically driven TLR

Primary Safety Endpoint

Occurrence of MAEs • All-cause death at 1 Month• TLR at 12 Months• Target limb major amputation at 12 Months

RANGER II SFAStudy Flow

Do Not Enroll

NO

NO

Guidewire crosses target lesionSuccessful pre-dilation

Obtain randomization code (3:1)

Post-dilation per discretionPost-procedure & Pre-discharge

Assessments

End of Study

Signed ICF & Baseline Testing

Eligibility criteria met

3:1282RANGER

investigational balloon 94Standard PTA

commercial balloon

NO

Follow-up Evaluations

Office : 1, 6, 12, 24, 36 Month FU

Office / Phone: 48, 60 Month FU

Prospective, multicenter, RCT 1:1:1

• N = 222

Prospective, multicenter, RCT 1:1N = 200

Prospective, RCT 1:1 (Ranger : InPact)N = 150 , study extended to 414 patients

Prospective, multicenter, registry N = 180

Feasibility, observational, angio F/UN = 30

Prospective, RCT 1:1 (Ranger vs PTA)N = 70

Prospective, multicenter, RCT 2:1 (JS+Ranger : POBA+Ranger)N = 250

Hemodialysis AVF Rescue

SPORTS

SFA RCT

SFA Registry

BTK Clinical

Investigator Sponsored Research Drug Elution (DES and DCB)

BTKAngiographic

JET-PCB(IDE)

These investigator-sponsored studies are supported by grant funding from Boston Scientific. Boston Scientific is not responsible for the collection, analysis or

reporting of these studies which remain the sole responsibility of the investigators. Information for the use in countries with applicable product registrations.

Clinical Study Overview: COMPARE I Pilot Study

TitleProspective, Randomized, Multi-center Study for the Treatment of Subjects with Symptomatic Femoropopliteal Artery Disease with the Ranger™ Paclitaxel Coated PTA Balloon Catheter (study arm) vs. the IN.PACT™ Drug Eluting Balloon (control arm)

Primary Investigator / Sponsor

Dierk Scheinert, MD – Germany

VascuScience GmbH – Leipzig, Germany

ObjectiveTo compare two different Paclitaxel coated balloons in the treatment of high grade stenotic or occluded lesions in the SFA and/of PPA

Study Design Prospective, multicenter, RCT 1:1 (Ranger DCB : InPact DCB)

Subjects 150 patients

Investigational Centers 15 centers in Germany

Primary Efficacy EndpointPatency rate after 1yr defined as absence of clinically driven TLR (due to symptoms and drop of ABI of ≥ 20% or > 0.15 when compared to post-procedure baseline) or restenosis with PVR > 2.4 evaluated by DUS

Primary Safety EndpointComposite of freedom from device and procedure-related death through 12m post procedure as well as freedom from both target limb major amputation and clinically-driven TVR

COMPARE I PilotInvestigator Sponsored Research

Clinical Study Overview: COMPARE I Pilot Study Extension

TitleProspective, Randomized, Multi-center Study for the Treatment of Subjects with Symptomatic Femoropopliteal Artery Disease with the Ranger™ Paclitaxel Coated PTA Balloon Catheter (study arm) vs. the IN.PACT™ Drug Eluting Balloon (control arm)

Primary Investigator / Sponsor

Dierk Scheinert, MD – Germany

VascuScience GmbH – Leipzig, Germany

ObjectiveTo compare two different Paclitaxel coated balloons in the treatment of high grade stenotic or occluded lesions in the SFA and/of PPA

Study Design Prospective, multicenter, RCT 1:1 (Ranger DCB : InPact DCB)

Subjects 150 patients 414 patients

Investigational Centers 15 centers in Germany

Primary Efficacy EndpointPatency rate after 1yr defined as absence of clinically driven TLR (due to symptoms and drop of ABI of ≥ 20% or > 0.15 when compared to post-procedure baseline) or restenosis with PVR > 2.4 evaluated by DUS

Primary Safety EndpointComposite of freedom from device and procedure-related death through 12m post procedure as well as freedom from both target limb major amputation and clinically-driven TVR

COMPARE I ExtenstionInvestigator Sponsored Research

SPORTS trialInvestigator Sponsored Research

Clinical Study Overview: JET-PCB Trial (Investigator sponsored IDE)

Title Sequent Please Drug coated balloons versus primary stent application in long SFA lesions

Primary Investigator / Sponsor

Prof. Dr. med. Gunnar Tepe - Germany

InnoRa GmbH Berlin

ObjectiveTo show superiority in terms of diameter stenosis 12 months after intervention of long lesionswith PES compared to NS (hypothesis 1a) and non-inferiority in terms of diameter stenosis 12 months after intervention of long lesions with PCB compared to NS (hypothesis 2a).

Study Design

A prospective, multicenter, open, RCT 1:1:1• PTA with PES• PTA with PCB• PTA with NSHypothesis 1a =

Study Devices PES – Eluvia™; PCB - SeQuent®; NS – SMART, Zilver, Innova, Absolut, LIfeStent, Everflex

Subjects 222 subjects (74 per treatment arm)

Investigational Centers 9 – 11 Centers in Germany and Austria

Primary Endpoint Percent diameter stenosis (DS) at 12 M as assessed by quantitative angiography

PES=paclitaxel-eluting stent; PCB=paclitaxel-coated balloon

PTA=Percutaneous transcatheter angioplasty; NS=Nitinol Stent

JET-PCB studyInvestigator Sponsored Research

Clinical Study Overview: JET-PCB Trial (Investigator sponsored IDE)

TitleJETStream Atherectomy with Adjunctive Paclitaxel-Coated Balloon Angioplasty vs Plain Old Balloon Angioplasty followed by Paclitaxel-Coated Balloon in Treating Complex Denovo FemoropoplitealArterial Disease

Primary Investigator / Sponsor

Nicolas W. Shammas, MD

Midwest Cardiovascular Research Foundation

Objective

To evaluate the use of Jetstream Atherectomy (JS) followed by DCB in comparison to the use of plain old balloon angioplasty (POBA) followed by DCB alone in the treatment of complex lesions in femoropopliteal arteries (Rutherford Cat 2-4)Complex lesions are defined:• Long lesions (≥ 10 cm)• Moderately or highly calcified lesions• Chronic total occlusions (irrespective of length)

Study Design A prospective, multicenter, 2:1 randomized (JS ath+Ranger DCB : POBA+DCB),

Subjects 250 subjects (~167 DCB+JS vs 83 POBA+DCB)

Investigational Centers Up to 25 study sites in US

Primary Efficacy Endpoint

TLR at 1 year, TLR defined as:• Retreatment of the index lesion (extended 1 cm prox and dist to the lesion) at 1 year.• For the primary endpoint, intra-procedural bail out stenting of the index lesion is considered

meeting a TLR endpoint

Primary Safety Endpoint

MAE at 30 days• Unplanned amputation• Total mortality• TLR (includes bailout stenting)

Below the Knee Studies - DCB

Ranger BTKA safety and efficacy study to evaluate Ranger drug-eluting

balloon for below the knee angioplasty in patients with critical limb ischemia

CRURAL DEBRandomized trial comparing drug coated balloon vs plain

balloon angioplasty in critical limb ischemia and treatment of long lesions in crural arteries

PI Marc Sapoval PI Torbjorn Fransson

Design Prospective, single centre, non-controlled, open-label

Design Prospective, single centre, randomized

Centres France Centres Sweden

Population 30 patients Population 70 patients

Primary Efficacy Endpoint

Primary patency (no stenosis >50%) and Late Lumen Loss (LLL) of the Target Lesion measured by Quantitative Vascular Angiography (QVA) at 6 months adjudicated by independent core lab

Primary EfficacyEndpoint

12 month primary patency

Primary Safety Endpoint

Composite of all death and major amputation at 6 and 12 months

SecondaryEndpoints

TLR, Event Free Survival, MRA analysis

Ranger DCB – BTKInvestigator Sponsored Research

Conclusions

• The amount of clinical data surrounding PAD therapies is rapidly increasing

• Boston Scientific has a broad portfolio of clinical studies with the goal of advancing the evidence for various PAD treatment technologies– Large Head-to-head randomized trials

– Complex lesions being studied

– Adjunctive therapies being studied

– Inclusion of more endpoints including cost effectiveness

• The future is exciting in the landscape for endovascular treatment for PAD, specifically in regards to Drug Elution technologies

• IMPORTANT INFORMATION: These materials are intended to describe common clinical considerations and procedural steps for the on-label use of referenced technologies as well as current standards of care for certain conditions. Of course, patients and their medical circumstances vary, so the clinical considerations and procedural steps described may not be appropriate for every patient or case. As always, decisions surrounding patient care depend on the physician’s professional judgment in light of all available information for the case at hand.

• BSC does not promote or encourage the use of its devices outside their approved labeling.

• The presenter’s experience with BSC products may not be interpreted or relied upon to support clinical claims about BSC devices or product comparison claims regarding BSC and competitive devices. The experiences of other users may vary.

• Results from case studies are not predictive of results in other cases. Results in other cases may vary.

Getting to answers with clinical trials: Being bold

Prof. Thomas ZellerDepartment AngiologyUniversity Heart-Center Freiburg - Bad KrozingenBad Krozingen , Germany