Trial Outcomes & Findings for Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females (CONFIRM) (NCT NCT02813577)

NCT ID: NCT02813577

Last Updated: 2020-04-24

Results Overview

Index limb amputation includes above or below the ankle amputations.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 4 participants
• Primary outcome timeframe: 12 months post index procedure
• Results posted on: 2020-04-24

Participant Flow

Participant milestones

Measure	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. Lutonix® 035 Drug Coated Balloon PTA Catheter: Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	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. Lutonix® 035 Drug Coated Balloon PTA Catheter: Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.
Overall Study Study terminated	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Lutonix® 035 Drug Coated Balloon PTA Catheter n=4 Participants This is a single-arm study. Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter. Lutonix® 035 Drug Coated Balloon PTA Catheter: Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.
Age, Customized ≥18 years of age	4 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months post index procedure

Population: Study was terminated.

Index limb amputation includes above or below the ankle amputations.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 12 months post index procedure

Population: Study was terminated.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days post index procedure

Population: Study was terminated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	Lutonix® 035 Drug Coated Balloon PTA Catheter n=4 Participants This is a single-arm study. Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter. Lutonix® 035 Drug Coated Balloon PTA Catheter: Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.
Number of Major Vascular Complications at 30 Days Post Index Procedure	0 Complications

SECONDARY outcome

Timeframe: 30 days post index procedure

Outcome measures

Measure	Lutonix® 035 Drug Coated Balloon PTA Catheter n=4 Participants This is a single-arm study. Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter. Lutonix® 035 Drug Coated Balloon PTA Catheter: Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.
Number of Deaths (All Causes) at 30 Days Post Index Procedure	0 Participants

SECONDARY outcome

Timeframe: 1, 6, 12 and 24 months post index procedure

Population: Study terminated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1, 6, 12 and 24 months post index procedure

Population: Study was terminated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1, 6, 12 and 24 months post index procedure

Population: Study was terminated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1, 6, 12 and 24 months post index procedure

Population: Study was terminated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1, 6, 12 and 24 months

Population: Study was terminated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1, 6, 12 and 24 months post index procedure

Population: Study was terminated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1, 6, 12 and 24 months post index procedure

Population: Study was terminated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1, 6, 12 and 24 months post index procedure

Population: Study was terminated.

Outcome measures

Outcome data not reported

Adverse Events

Lutonix® 035 Drug Coated Balloon PTA Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anna Lovas

Becton Dickinson

Phone: 763-445-2385

Email: anna.lovas@bd.com

Results disclosure agreements

• Principal investigator is a sponsor employee Prior to PI publication of site results, sponsor requires publication of multi-centers results.
• Publication restrictions are in place

Restriction type: OTHER