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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 : Recruiting
First Posted : June 27, 2016
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
C. R. Bard

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.

Condition or disease Intervention/treatment Phase
Femoral Artery Stenosis Popliteal Artery Stenosis Femoral Artery Occlusion Popliteal Artery Occlusion Device: Lutonix® 035 Drug Coated Balloon PTA Catheter Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Single Arm, Post-Approval Study of the Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females
Actual Study Start Date : April 20, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
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.
Device: Lutonix® 035 Drug Coated Balloon PTA Catheter
Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.




Primary Outcome Measures :
  1. 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 ]
  2. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. Major Vascular Complications [ Time Frame: 30 days ]
  3. All-cause death [ Time Frame: 1, 6, 12 and 24 months ]
  4. Clinically Driven Target Lesion Revascularization (TLR) [ Time Frame: 1, 6, 12 and 24 months ]
  5. Target Vessel Revascularization (TVR) [ Time Frame: 1, 6, 12 and 24 months ]
  6. Reintervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature [ Time Frame: 1, 6, 12 and 24 months ]
  7. Rate of unanticipated and anticipated device related serious adverse events [ Time Frame: 1, 6, 12 and 24 months ]
  8. Amputation (above the ankle)-Free Survival (AFS) [ Time Frame: 1, 6, 12 and 24 months ]
  9. Change of Rutherford classification from baseline [ Time Frame: 1, 6, 12 and 24 months ]
  10. Sustained Clinical Benefit [ Time Frame: 1, 6, 12 and 24 months ]
    Improvement in Rutherford Class compared to baseline AND freedom from target vessel revascularization

  11. Change of resting Ankle Brachial Index (ABI) from baseline [ Time Frame: 1, 6, 12 and 24 months ]


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

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.

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): NCT02813577


Contacts
Contact: Anna Lovas 763.445.2385 Anna.Lovas@crbard.com
Contact: Sharon Christensen 763-390-8668 Sharon.Christensen@crbard.com

Locations
United States, Indiana
St. Vincent Medical Group Recruiting
Indianapolis, Indiana, United States, 46290
Contact: Anna Lovas       anna.lovas@crbard.com   
Principal Investigator: Kannan Natarajan         
United States, Iowa
Midwest Cardiovascular Research Foundation Recruiting
Davenport, Iowa, United States, 52803
Contact: Anna Lovas       anna.lovas@crbard.com   
Principal Investigator: Nicolas Shammas, MD         
Sub-Investigator: Shawna Duske, ARNP         
United States, South Carolina
Vascular Access Solutions Recruiting
Orangeburg, South Carolina, United States, 29118
Contact: Anna Lovas       anna.lovas@crbard.com   
Principal Investigator: Dion Franga, MD         
United States, Tennessee
Wellmont CVA Heart Institute Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Anna Lovas       anna.lovas@crbard.com   
Principal Investigator: Christopher Metzger, MD         
Sponsors and Collaborators
C. R. Bard
Investigators
Principal Investigator: Christopher Metzger, MD Wellmont CVA Heart Institute

Additional Information:
Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT02813577     History of Changes
Other Study ID Numbers: CL0025-01
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by C. R. Bard:
Legs
Drug Coated Angioplasty Balloon
Experimental
Standard Angioplasty Balloon

Additional relevant MeSH terms:
Constriction, Pathologic
Arterial Occlusive Diseases
Pathological Conditions, Anatomical
Vascular Diseases
Cardiovascular Diseases