Clinical trial NCT02063672: Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Artery Stenosis
Femoral Artery Occlusion
Restenosis
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2014-02-14
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.)

Primary outcomes:
measure: Percentage of Participants With Primary Patency at 1 Year
timeFrame: 12 Months
measure: Percentage of Participants Without Primary Safety Events
timeFrame: 12 Months
Secondary outcomes:
measure: Percentage of Participants With Device Success
timeFrame: During the Index Procedure (90 mins)
measure: Percentage of Participants With Technical Success
timeFrame: During the Index Procedure (90 mins)
measure: Percentage of Participants With Procedural Success
timeFrame: During the Index Procedure (90 mins)
measure: Percentage of Participants With Primary Patency at 6 and 12 Months
timeFrame: 6 months and 12 months
measure: Percentage of Participants With Secondary Patency at 6 Months and 12 Months
timeFrame: 6 months and 12 months
measure: Percentage of Participants Without Clinically Driven Target Lesion Revascularization (TLR)
timeFrame: 6 months and 12 months
measure: Percentage of Participants Without Target Lesion Revascularization (TLR)
timeFrame: 6 months and 12 months
measure: Percentage of Participants With Sustained Clinical Benefit Compared to Baseline
timeFrame: 6 months and 12 months
measure: Change of Rutherford Classification From Baseline
timeFrame: 6 months and 12 months
measure: Change of Resting Ankle Brachial Index (ABI) From Baseline
timeFrame: 6 months and 12 months
measure: Change in Walking Impairment Questionnaire From Baseline
timeFrame: 6 months and 12 months
measure: Change in Quality of Life From Baseline
timeFrame: 6 months and 12 Months
measure: Percentage of Participants Without Major Vascular Complications (≤30 Day)
timeFrame: 30 Days
measure: Percentage of Participants Without All-Cause Death
timeFrame: 1 month, 6 months, and 12 months
measure: Percentage of Participants Without Major Limb Amputation
timeFrame: 1 month, 6 months, and 12 months
measure: Percentage of Participants Without Minor Limb Amputation
timeFrame: 1 month, 6 months, and 12 months
measure: Percentage of Participants Without Target Vessel Revascularizations (TVR)
timeFrame: 1 month, 6 months, and 12 months
measure: Percentage of Participants Without Any Target Limb Reinterventions
timeFrame: 1 month, 6 months, and 12 months
Other outcomes:
Locations:
city: Fairhope
country: United States
facility: Cardiology Associates
state: Alabama
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Washington
country: United States
facility: MedStar Health Research Institute
state: District of Columbia
city: Lakeland
country: United States
facility: Radiology and Imaging Specialists of Lakeland, P.A.
state: Florida
city: Miami
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Royal Oak
country: United States
facility: William Beaumont Hospital Research Institute
state: Michigan
city: Wyoming
country: United States
facility: Metropolitan Hospital d/b/a Metro Health Hospital
state: Michigan
city: Plymouth
country: United States
facility: Minneapolis Radiology and Vascular Research Foundation
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic, PA
state: Mississippi
city: Jackson
country: United States
facility: Jackson Heart Clinic, P.A.
state: Mississippi
city: North Kansas City
country: United States
facility: Kansas City Vascular Foundation
state: Missouri
city: Flemington
country: United States
facility: Hunterdon Cardiovascular Associates
state: New Jersey
city: Raleigh
country: United States
facility: Rex Hospital, Inc.
state: North Carolina
city: Cincinnati
country: United States
facility: TriHealth, Inc.
state: Ohio
city: Providence
country: United States
facility: The Miriam Hospital - A Lifespan Partner
state: Rhode Island
city: Kingsport
country: United States
facility: Wellmont Cardiology Services, Inc.
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Milwaukee
country: United States
facility: Aurora Medical Group
state: Wisconsin
Study officials:
affiliation: Yale University
name: Carlos Mena, MD
role: PRINCIPAL_INVESTIGATOR
References: