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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by C. R. Bard
Information provided by (Responsible Party):
C. R. Bard Identifier:
First received: February 12, 2014
Last updated: September 20, 2016
Last verified: September 2016
To assess the safety and efficacy of the Lutonix Drug Coated Balloon for treatment of femoropopliteal artery (SFA) in-stent restenosis (ISR).

Condition Intervention Phase
Femoral Artery Stenosis
Femoral Artery Occlusion
Device: Lutonix DCB
Device: Standard Uncoated Balloon Angioplasty Catheter
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • Efficacy: Primary Patency [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Primary patency is defined as freedom from clinically driven TLR and from Binary Restenosis.

  • Safety: Freedom from all cause perioperative death, index limb amputation, index limb reintervention and index limb related death. [ Time Frame: 30 Days and 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Primary and Secondary Patency (DUS PSVR <2.5) [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
  • Target Lesion Revascularization (TLR) [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
  • Change of Rutherford classification from baseline [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
  • Change of resting Ankle Brachial Index (ABI) from baseline [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
  • Change in Walking Impairment Questionnaire from baseline [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
  • Change in quality of life from baseline, as measured by EQ-5D [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
  • Major vascular complications (≤30 day) [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: March 2014
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lutonix DCB
Lutonix Paclitaxel Drug Coated Balloon
Device: Lutonix DCB
Active Comparator: PTA Catheter
Standard Uncoated Balloon Angioplasty Catheter
Device: Standard Uncoated Balloon Angioplasty Catheter
PTA Catheter


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02063672

Contact: Heidi Ronhovde

  Show 25 Study Locations
Sponsors and Collaborators
C. R. Bard
Principal Investigator: Carlos Mena, MD Yale University
  More Information

Responsible Party: C. R. Bard Identifier: NCT02063672     History of Changes
Other Study ID Numbers: CL0018-01 
Study First Received: February 12, 2014
Last Updated: September 20, 2016
Health Authority: United States: Food and Drug Administration processed this record on December 08, 2016