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

Not Applicable

Completed

Conditions: Femoral Artery Stenosis
Restenosis
Femoral Artery Occlusion

Interventions: Device: Standard Uncoated Balloon Angioplasty Catheter
Device: Lutonix DCB

Registration Number: NCT02063672

Lead Sponsor: C. R. Bard

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 82

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

Key

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.)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTA Catheter	Standard Uncoated Balloon Angioplasty Catheter	Standard Uncoated Balloon Angioplasty Catheter
Lutonix DCB	Lutonix DCB	Lutonix Paclitaxel Drug Coated Balloon

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Without Primary Safety Events	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	12 Months	Primary patency is defined as freedom from clinically driven target lesion restenosis (TLR) and from Binary Restenosis.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Without All-Cause Death	1 month, 6 months, and 12 months	Mortality from any cause.
Percentage of Participants Without Target Lesion Revascularization (TLR)	6 months and 12 months	TLR is defined as any repeat revascularization procedure (percutaneous or surgical) of the original target lesion site.
Percentage of Participants With Device Success	During the Index Procedure (90 mins)	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.
Percentage of Participants With Primary Patency at 6 and 12 Months	6 months 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).
Percentage of Participants Without Major Vascular Complications (≤30 Day)	30 Days	Freedom from major vascular complications at 30 days follow-up
Change in Walking Impairment Questionnaire From Baseline	6 months and 12 months	The Walking Impairment Questionnaire (WIQ) is a validated questionnaire that evaluates walking ability with a focus on walking distance, walking speed, and the ability to climb stairs. Participants answer each item on a Likert scale from 0 for "unable to do" to 4 for "no difficulty", and each response is weighted based on the difficulty of the task. The overall score is determined by dividing the weighted answers by the maximum possible weighted score and multiplying by 100. The overall score ranges from 0-100 with lower scores indicating lower performance.
Percentage of Participants With Technical Success	During the Index Procedure (90 mins)	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.
Percentage of Participants With Procedural Success	During the Index Procedure (90 mins)	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.
Percentage of Participants Without Clinically Driven Target Lesion Revascularization (TLR)	6 months and 12 months	Clinically-driven TLR is defined as revascularization of the target vessel with evidence of target vessel diameter stenosis \>50% determined by duplex ultrasound or angiography and new distal ischemic signs (worsening ABI or worsening Rutherford Category associated with the target limb or due to clinical symptoms), OR revascularization of a target vessel with an in-lesion diameter stenosis of \>70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms.
Percentage of Participants With Sustained Clinical Benefit Compared to Baseline	6 months and 12 months	Sustained clinical benefit is defined as an improvement in Rutherford Classification compared to baseline and freedom from target vessel revascularization. The Rutherford classification is a clinical means of describing peripheral artery disease along a seven-stage scale, with stage 0 representing asymptomatic presentation and stage 6 representing severe ischemic ulcers or frank gangrene. A decrease in units on the scale represents improvement in clinical symptoms.
Percentage of Participants Without Major Limb Amputation	1 month, 6 months, and 12 months	Major limb amputation is defined as amputation of the lower limb above the ankle.
Percentage of Participants With Secondary Patency at 6 Months and 12 Months	6 months and 12 months	Secondary patency is defined as the absence of Binary Restenosis as adjudicated by the blinded, independent core laboratory, independent of whether or not patency is re-established via an endovascular procedure.
Change of Rutherford Classification From Baseline	6 months and 12 months	The Rutherford classification is a clinical means of describing peripheral artery disease along a seven-stage scale, with stage 0 representing asymptomatic presentation and stage 6 representing severe ischemic ulcers or frank gangrene. A decrease in units on the scale represents improvement in clinical symptoms.
Change of Resting Ankle Brachial Index (ABI) From Baseline	6 months and 12 months	The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium).
Change in Quality of Life From Baseline	6 months and 12 Months	EQ-5D is a standardized tool to assess patient-reported mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, or slight, moderate, severe, or extreme problems. Patients choose the appropriate level in each of the 5 dimensions, which results in a 1-digit number for each dimension. The digits for the 5 dimensions are converted into a single EQ-5D™ index score based on a set of population-based preference weights. For the U.S. general population, possible EQ-5D™ index scores range from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on a scale where 0.0 = death and 1.0 = perfect health. A downloadable scoring file is available at: https://www.ahrq.gov/rice/EQ5Dscore.htm. The EQ VAS records a patient's self-rated health on a vertical visual analogue scale, where the endpoints are labeled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0). A higher VAS value indicates a higher quality of life.
Percentage of Participants Without Minor Limb Amputation	1 month, 6 months, and 12 months	Minor limb amputation is defined as amputation of a part of the foot below the ankle.
Percentage of Participants Without Target Vessel Revascularizations (TVR)	1 month, 6 months, and 12 months	A TVR is defined as a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel.
Percentage of Participants Without Any Target Limb Reinterventions	1 month, 6 months, and 12 months	Any surgical intervention in the target limb.

Trial Locations

Locations (20): Rex Hospital, Inc.
🇺🇸
Raleigh, North Carolina, United States
Mount Sinai Medical Center
🇺🇸
Miami, Florida, United States
Hunterdon Cardiovascular Associates
🇺🇸
Flemington, New Jersey, United States
Wellmont Cardiology Services, Inc.
🇺🇸
Kingsport, Tennessee, United States
Cardiology Associates
🇺🇸
Fairhope, Alabama, United States
Northwestern University
🇺🇸
Evanston, Illinois, United States
Kansas City Vascular Foundation
🇺🇸
North Kansas City, Missouri, United States
The Miriam Hospital - A Lifespan Partner
🇺🇸
Providence, Rhode Island, United States
University of Texas Medical Branch
🇺🇸
Galveston, Texas, United States
Minneapolis Radiology and Vascular Research Foundation
🇺🇸
Plymouth, Minnesota, United States
Radiology and Imaging Specialists of Lakeland, P.A.
🇺🇸
Lakeland, Florida, United States
MedStar Health Research Institute
🇺🇸
Washington, District of Columbia, United States
Metropolitan Hospital d/b/a Metro Health Hospital
🇺🇸
Wyoming, Michigan, United States
Hattiesburg Clinic, PA
🇺🇸
Hattiesburg, Mississippi, United States
William Beaumont Hospital Research Institute
🇺🇸
Royal Oak, Michigan, United States
Jackson Heart Clinic, P.A.
🇺🇸
Jackson, Mississippi, United States
TriHealth, Inc.
🇺🇸
Cincinnati, Ohio, United States
Virginia Commonwealth University
🇺🇸
Richmond, Virginia, United States
Yale University
🇺🇸
New Haven, Connecticut, United States
Aurora Medical Group
🇺🇸
Milwaukee, Wisconsin, United States