A Prospective, Multicenter, Single-Blind, Randomized, Controlled Trial Comparing the Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis

C. R. Bard20 sites in 1 country82 target enrollmentMarch 2014

ConditionsFemoral Artery Stenosis Femoral Artery Occlusion Restenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Femoral Artery Stenosis
Sponsor: C. R. Bard
Enrollment: 82
Locations: 20
Primary Endpoint: Percentage of Participants Without Primary Safety Events
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

March 2014

End Date

March 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

C. R. Bard

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or non-pregnant female ≥18 years of age
•Rutherford Clinical Category 2-4
•Significant (≥ 50%) restenosis of a previous bare (not covered and not drug-eluting) nitinol stent(s) in the femoropopliteal artery
•Lesion measures between 4 and 18 cm
•Target vessel diameter between ≥4 and ≤6 mm and able to be treated with available device size matrix
•A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography
•Successful crossing and predilatation of the target lesion with a guidewire
•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
•No other prior vascular or surgical interventions within 2 weeks before and/or planned 30 days after the protocol treatment

Exclusion Criteria

•Life expectancy of \<1 year
•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
•History of stroke within 3 months
•History of MI, thrombolysis or angina within 2 weeks of enrollment
•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
•Target lesion involves a previously placed covered stent or drug-eluting stent
•Grade 4 or 5 stent fracture (mal-aligned components or trans-axial spiral configuration) in the restenotic stent
•Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication
•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
•Intended use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, stents, etc.)

Outcomes

Primary Outcomes

Percentage of Participants Without Primary Safety Events

Time Frame: 12 Months

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

Percentage of Participants With Primary Patency at 1 Year

Time Frame: 12 Months

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

Secondary Outcomes

Percentage of Participants Without Target Lesion Revascularization (TLR)(6 months and 12 months)
Percentage of Participants With Device Success(During the Index Procedure (90 mins))
Percentage of Participants With Primary Patency at 6 and 12 Months(6 months and 12 months)
Change in Walking Impairment Questionnaire From Baseline(6 months and 12 months)
Percentage of Participants With Technical Success(During the Index Procedure (90 mins))
Percentage of Participants With Procedural Success(During the Index Procedure (90 mins))
Percentage of Participants Without Clinically Driven Target Lesion Revascularization (TLR)(6 months and 12 months)
Percentage of Participants With Sustained Clinical Benefit Compared to Baseline(6 months and 12 months)
Percentage of Participants Without Major Vascular Complications (≤30 Day)(30 Days)
Percentage of Participants Without All-Cause Death(1 month, 6 months, and 12 months)
Percentage of Participants Without Major Limb Amputation(1 month, 6 months, and 12 months)
Percentage of Participants With Secondary Patency at 6 Months and 12 Months(6 months and 12 months)
Change of Rutherford Classification From Baseline(6 months and 12 months)
Change of Resting Ankle Brachial Index (ABI) From Baseline(6 months and 12 months)
Change in Quality of Life From Baseline(6 months and 12 Months)
Percentage of Participants Without Minor Limb Amputation(1 month, 6 months, and 12 months)
Percentage of Participants Without Target Vessel Revascularizations (TVR)(1 month, 6 months, and 12 months)
Percentage of Participants Without Any Target Limb Reinterventions(1 month, 6 months, and 12 months)