ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    CL0018-01
Previous Study | Return to List | Next Study

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.
ClinicalTrials.gov Identifier: NCT02063672
Recruitment Status : Active, not recruiting
First Posted : February 14, 2014
Results First Posted : May 23, 2018
Last Update Posted : June 12, 2018
Sponsor:
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 : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

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. 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.

  2. 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


Secondary Outcome Measures :
  1. Percentage of Participants With Device Success [ Time Frame: 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.

  2. Percentage of Participants With Technical Success [ Time Frame: 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.

  3. Percentage of Participants With Procedural Success [ Time Frame: 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.

  4. Percentage of Participants With Primary Patency at 6 and 12 Months [ Time Frame: 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).

  5. Percentage of Participants With Secondary Patency at 6 Months and 12 Months [ Time Frame: 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.

  6. Percentage of Participants Without Clinically Driven Target Lesion Revascularization (TLR) [ Time Frame: 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.

  7. Percentage of Participants Without Target Lesion Revascularization (TLR) [ Time Frame: 6 months and 12 months ]
    TLR is defined as any repeat revascularization procedure (percutaneous or surgical) of the original target lesion site.

  8. Percentage of Participants With Sustained Clinical Benefit Compared to Baseline [ Time Frame: 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.

  9. Change of Rutherford Classification From Baseline [ Time Frame: 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.

  10. Change of Resting Ankle Brachial Index (ABI) From Baseline [ Time Frame: 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).

  11. Change in Walking Impairment Questionnaire From Baseline [ Time Frame: 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.

  12. Change in Quality of Life From Baseline [ Time Frame: 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.


  13. Percentage of Participants Without Major Vascular Complications (≤30 Day) [ Time Frame: 30 Days ]
    Freedom from major vascular complications at 30 days follow-up

  14. Percentage of Participants Without All-Cause Death [ Time Frame: 1 month, 6 months, and 12 months ]
    Mortality from any cause.

  15. Percentage of Participants Without Major Limb Amputation [ Time Frame: 1 month, 6 months, and 12 months ]
    Major limb amputation is defined as amputation of the lower limb above the ankle.

  16. Percentage of Participants Without Minor Limb Amputation [ Time Frame: 1 month, 6 months, and 12 months ]
    Minor limb amputation is defined as amputation of a part of the foot below the ankle.

  17. Percentage of Participants Without Target Vessel Revascularizations (TVR) [ Time Frame: 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.

  18. Percentage of Participants Without Any Target Limb Reinterventions [ Time Frame: 1 month, 6 months, and 12 months ]
    Any surgical intervention in the target limb.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)

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 ClinicalTrials.gov identifier (NCT number): NCT02063672


  Show 20 Study Locations
Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: Carlos Mena, MD Yale University
  Study Documents (Full-Text)

Documents provided by C. R. Bard:
Study Protocol  [PDF] February 19, 2016
Statistical Analysis Plan  [PDF] June 8, 2016


Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT02063672     History of Changes
Other Study ID Numbers: CL0018-01
First Posted: February 14, 2014    Key Record Dates
Results First Posted: May 23, 2018
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No