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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02063672
Recruitment Status : Active, not recruiting
First Posted : February 14, 2014
Last Update Posted : April 4, 2017
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Femoral Artery Stenosis Femoral Artery Occlusion Restenosis Device: Lutonix DCB Device: Standard Uncoated Balloon Angioplasty Catheter Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : March 2014
Actual Primary Completion Date : February 13, 2017
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Efficacy: Primary Patency [ Time Frame: 12 Months ]
    Primary patency is defined as freedom from clinically driven TLR and from Binary Restenosis.

  2. 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02063672

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Sponsors and Collaborators
C. R. Bard
Principal Investigator: Carlos Mena, MD Yale University

Responsible Party: C. R. Bard Identifier: NCT02063672     History of Changes
Other Study ID Numbers: CL0018-01
First Posted: February 14, 2014    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No