Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis

N/ACompletedNCT02063672

C. R. Bard82 enrolled

Overview

To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Femoral Artery Stenosis Femoral Artery Occlusion Restenosis

Interventions

Lutonix DCBDEVICE

Standard Uncoated Balloon Angioplasty CatheterDEVICE

PTA Catheter

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. Male or non-pregnant female ≥18 years of age 2. Rutherford Clinical Category 2-4 3. Significant (≥ 50%) restenosis of a previous bare (not covered and not drug-eluting) nitinol stent(s) in the femoropopliteal artery 4. Lesion measures between 4 and 18 cm 5. Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix 6. A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography 7. Successful crossing and predilatation of the target lesion with a guidewire 8. At least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography that has not previously been (nor planned to be) revascularized 9. No other prior vascular or surgical interventions within 2 weeks before and/or planned 30 days after the protocol treatment Key Exclusion Criteria: 1. Life expectancy of \<1 year 2. Patient is currently participating in an investigational drug or other device study or previously enrolled in this study NOTE: Enrollment in another drug or device clinical trial during the follow up period is not allowed 3. History of stroke within 3 months 4. History of MI, thrombolysis or angina within 2 weeks of enrollment 5. Prior vascular surgery of the index limb, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion 6. Target lesion involves a previously placed covered stent or drug-eluting stent 7. Grade 4 or 5 stent fracture (mal-aligned components or trans-axial spiral configuration) in the restenotic stent 8. Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication 9. Known inadequate distal outflow (\>50 % stenosis of distal popliteal and/or all three tibial vessels), or planned future treatment of vascular disease distal to the target lesion 10. Intended use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, stents, etc.)

Locations (20)

Cardiology Associates

Fairhope, Alabama, United States

Outcomes

Primary Outcomes

Percentage of Participants With Primary Patency at 1 Year

Primary patency is defined as freedom from clinically driven target lesion restenosis (TLR) and from Binary Restenosis.

Time frame: 12 Months

Percentage of Participants Without Primary Safety Events

Primary Safety Events include: All Cause Perioperative (≤30 day) Death, Index Limb Amputation, Index Limb Reintervention and Index Limb Related Death at 1 Year

Time frame: 12 Months

Secondary Outcomes

Percentage of Participants With Device Success

Device success is defined as, on a per device basis, the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the study system.

Time frame: During the Index Procedure (90 mins)

Percentage of Participants With Technical Success

Technical success of the balloon procedure is defined as the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion and a successful withdrawal of the study system with the achievement of \< 30% residual percent stenosis without deployment of a bail-out stent.

Time frame: During the Index Procedure (90 mins)

Percentage of Participants With Procedural Success

Procedural Success is defined as attainment of ≤30% residual stenosis in the treatment area by independent core lab analysis without major adverse events (defined as occurrence of death, amputation of the target limb, or repeat revascularization of the target lesion) during the index procedure and through the hospital stay.

Time frame: During the Index Procedure (90 mins)

Data from ClinicalTrials.gov

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New Haven, Connecticut, United States

MedStar Health Research Institute

Washington D.C., District of Columbia, United States

Radiology and Imaging Specialists of Lakeland, P.A.

Lakeland, Florida, United States

Mount Sinai Medical Center

Miami, Florida, United States

Northwestern University

Evanston, Illinois, United States

William Beaumont Hospital Research Institute

Royal Oak, Michigan, United States

Metropolitan Hospital d/b/a Metro Health Hospital

Wyoming, Michigan, United States

Minneapolis Radiology and Vascular Research Foundation

Plymouth, Minnesota, United States

Hattiesburg Clinic, PA

Hattiesburg, Mississippi, United States

...and 10 more locations

Percentage of Participants With Primary Patency at 6 and 12 Months

Primary Patency is defined as Freedom from CEC-adjudicated Clinically-Driven TLR and from Core laboratory-adjudicated Binary Restenosis. Binary restenosis is based on threshold Doppler peak systolic velocity ratio (PSVR) ≥ 2.5 (together with waveform analysis \& color mosaic appearance) or based on angiographic ≥ 50% diameter stenosis (if angiography is performed although not required per protocol).