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

April 10, 2020 updated by: C. R. Bard

A Prospective, Multicenter, Single Arm, Post-Approval Study of the Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • St. Vincent Medical Group
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Midwest Cardiovascular Research Foundation
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • Vascular Access Solutions
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Wellmont CVA Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Freedom From the Following: All-cause Peri-operative Death at 30 Days, Index Limb Amputation Within 1 Year, Index Limb Re-intervention Within 1 Year, and Index-limb-Related Death Within 1 Year Post Index Procedure
Time Frame: 12 months post index procedure
Index limb amputation includes above or below the ankle amputations.
12 months post index procedure
Effectiveness: Number of Participants With Primary Patency of the Target Lesion at 12 Month Post Index Procedure.
Time Frame: 12 months post index procedure
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.
12 months post index procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of Participants With 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 post index procedure
30 days post index procedure
Number of Major Vascular Complications at 30 Days Post Index Procedure
Time Frame: 30 days
30 days
Number of Deaths (All Causes) at 30 Days Post Index Procedure
Time Frame: 30 days post index procedure
30 days post index procedure
Number of Participants With Clinically Driven Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Month Post Index Procedure
Time Frame: 1, 6, 12 and 24 months post index procedure
1, 6, 12 and 24 months post index procedure
Number of Participants With Target Vessel Revascularization (TVR) at 1, 6, 12, and 24 Months Post Index Porcedure
Time Frame: 1, 6, 12 and 24 months post index procedure
1, 6, 12 and 24 months post index procedure
Number of Participants With Reintervention for Treatment of Thrombosis of the Target Vessel or Embolization to Its Distal Vasculature at 1, 6, 12, and 24 Months Post Index Procedure
Time Frame: 1, 6, 12 and 24 months post index procedure
1, 6, 12 and 24 months post index procedure
Number of Participants With Unanticipated and Anticipated Device Related Serious Adverse Events at 1, 6, 12, and 24 Months Post Index Procedure
Time Frame: 1, 6, 12 and 24 months post index procedure
1, 6, 12 and 24 months post index procedure
Number of Participants With Amputation (Above the Ankle)-Free Survival (AFS) at 1, 6, 12, and 24 Months Post Index Procedure.
Time Frame: 1, 6, 12 and 24 months
1, 6, 12 and 24 months
Change in Rutherford Classification Scores at 1, 6, 12, and 24 Months Post Index Procedure Compared to Baseline
Time Frame: 1, 6, 12 and 24 months post index procedure
1, 6, 12 and 24 months post index procedure
Number of Participants With Sustained Clinical Benefit at 1, 6, 12, and 24 Months Post Index Procedure
Time Frame: 1, 6, 12 and 24 months post index procedure
1, 6, 12 and 24 months post index procedure
Change of Resting Ankle Brachial Index (ABI) Scores at 1, 6, 12, and 24 Months Post Index Procedure Compared to Baseline
Time Frame: 1, 6, 12 and 24 months post index procedure
1, 6, 12 and 24 months post index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
C. R. Bard

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher Metzger, MD, Wellmont CVA Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 18, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 18, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CL0025-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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