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Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females (CONFIRM) (CONFIRM)

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ClinicalTrials.gov Identifier: NCT02813577
Recruitment Status : Terminated (FDA allowed other data to be leveraged to meet the study requirements)
First Posted : June 27, 2016
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
C. R. Bard

Tracking Information
First Submitted Date  ICMJE June 16, 2016
First Posted Date  ICMJE June 27, 2016
Last Update Posted Date March 7, 2019
Actual Study Start Date  ICMJE April 20, 2018
Actual Primary Completion Date February 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2018)
  • Safety: composite of freedom from all of the following: all-cause peri-operative death within 30 days, index limb amputation (above or below the ankle) within 1 year, index limb re-intervention within 1 year, and index-limb-related death within 1 year. [ Time Frame: 12 Months ]
  • Effectiveness: Primary patency of the target lesion at 12 months. [ Time Frame: 12 Months ]
    Primary patency is defined as freedom from target lesion restenosis (TLR) and from binary restenosis. Binary restenosis is adjudicated by the independent Core Laboratory based on Peak Systolic Velocity Ratio (PSVR) ≥ 2.5 and / or abnormal waveforms, or based on angiographic ≥ 50% diameter stenosis.
Original Primary Outcome Measures  ICMJE
 (submitted: June 24, 2016)
  • Safety: Freedom from all of the following: all-cause peri-operative death within 30 days, index limb amputation (above or below the ankle) within 1 year, index limb re-intervention within 1 year, and index-limb-related death within 1 year. [ Time Frame: 12 Months ]
  • Effectiveness: Primary Patency (Primary patency is defined as the absence of target lesion restenosis (defined by DUS PSVR ≥2.5) and freedom from target lesion revascularization (TLR) [ Time Frame: 12 Months ]
Change History Complete list of historical versions of study NCT02813577 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2018)
  • Composite of freedom from all-cause perioperative (≤ 30 day) death and freedom from the following: index limb amputation, index limb re-intervention, and index-limb-related death. [ Time Frame: 30 days ]
  • Major Vascular Complications [ Time Frame: 30 days ]
  • All-cause death [ Time Frame: 1, 6, 12 and 24 months ]
  • Clinically Driven Target Lesion Revascularization (TLR) [ Time Frame: 1, 6, 12 and 24 months ]
  • Target Vessel Revascularization (TVR) [ Time Frame: 1, 6, 12 and 24 months ]
  • Reintervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature [ Time Frame: 1, 6, 12 and 24 months ]
  • Rate of unanticipated and anticipated device related serious adverse events [ Time Frame: 1, 6, 12 and 24 months ]
  • Amputation (above the ankle)-Free Survival (AFS) [ Time Frame: 1, 6, 12 and 24 months ]
  • Change of Rutherford classification from baseline [ Time Frame: 1, 6, 12 and 24 months ]
  • Sustained Clinical Benefit [ Time Frame: 1, 6, 12 and 24 months ]
    Improvement in Rutherford Class compared to baseline AND freedom from target vessel revascularization
  • Change of resting Ankle Brachial Index (ABI) from baseline [ Time Frame: 1, 6, 12 and 24 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2016)
  • Rate of unanticipated and anticipated device related serious adverse events [ Time Frame: 1, 6, 12, and 24 Months ]
  • All-cause death [ Time Frame: 1, 6, 12, and 24 Months ]
  • Target Lesion Revascularization (TLR) which is a repeat revascularization procedure (percutaneous or surgical) of the original target lesion treatment area. [ Time Frame: 1, 6, 12, and 24 Months ]
  • Major Vascular Complications which includes following: Haematoma at access site >5cm, False aneurysm, AV fistula, Retroperitoneal bleed, Peripheral ischemia/nerve injury, Transfusion, Vascular surgical repair [ Time Frame: 30 days ]
    Any transfusion required will be reported as a vascular complication unless clinical indication Any transfusion required will be reported as a vascular complication unless clinical indication clearly other than catheterization complication
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females (CONFIRM)
Official Title  ICMJE A Prospective, Multicenter, Single Arm, Post-Approval Study of the Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females
Brief Summary The post approval study will enroll US female patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects are treated per Instructions For Use (IFU) with the Lutonix® Catheter. Subjects will have a Duplex Ultrasound (DUS) and clinical follow-up through two (2) years.
Detailed Description The Lutonix® 035 Drug Coated Balloon PTA Catheter (Lutonix® Catheter) has been approved by the Food and Drug Administration (P130024) for percutaneous transluminal angioplasty, after appropriate vessel preparation of de novo, restenotic, or in-stent restenotic lesions up to 300 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm. The purpose of this post-approval study is to assess the safety and effectiveness of the Lutonix® Catheter in the US female population. This study will enroll approximately 165 female patients at a minimum of 10 US centers and a maximum of 25.
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Femoral Artery Stenosis
  • Popliteal Artery Stenosis
  • Femoral Artery Occlusion
  • Popliteal Artery Occlusion
Intervention  ICMJE Device: Lutonix® 035 Drug Coated Balloon PTA Catheter
Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.
Study Arms Lutonix® 035 Drug Coated Balloon PTA Catheter
This is a single-arm study. Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.
Intervention: Device: Lutonix® 035 Drug Coated Balloon PTA Catheter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 5, 2019)
4
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2016)
160
Actual Study Completion Date February 18, 2019
Actual Primary Completion Date February 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Clinical Criteria

  1. Non-pregnant female ≥18 years of age;
  2. Rutherford Clinical Category 2-4;
  3. Patient is willing to provide informed consent, is geographically stable, comply with the required follow up visits and testing schedule;

    Angiographic Criteria

  4. De novo or restenotic lesion(s) in native superficial femoral or popliteal arteries;
  5. Lesion ≥70% stenosis by visual estimate;
  6. Target reference vessel diameter of 4-7 mm;
  7. A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography; (Treatment of target lesion acceptable after successful treatment of inflow artery lesions. Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤30% without death or major vascular complication.)
  8. At least one patent native outflow artery to the ankle, free from significant (≥50%) stenosis as confirmed by angiography after successful vessel preparation;
  9. Successful antegrade wire crossing and vessel preparation (may include pre-dilatation) of the target lesion. Successful vessel preparation is defined by residual stenosis ≤30% without any major vascular complications;
  10. No other prior vascular interventions within 2 weeks before and/or planned 30 days after the protocol treatment except for remote common femoral patch angioplasty separated by at least 2 cm from the lesion(s).

Exclusion Criteria

  1. Life expectancy of <2 years;
  2. Subject is currently participating in an investigational drug or device study, or previously enrolled in this study. Enrollment in another investigational drug or device study during the follow up period is not allowed;
  3. History of stroke within 3 months;
  4. History of myocardial infarction (MI), thrombolysis or angina within 2 weeks of index procedure;
  5. Renal failure or chronic kidney disease with serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis;
  6. Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02813577
Other Study ID Numbers  ICMJE CL0025-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party C. R. Bard
Study Sponsor  ICMJE C. R. Bard
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher Metzger, MD Wellmont CVA Heart Institute
PRS Account C. R. Bard
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP