IN.PACT™ Quality of Life Post-Reimbursement Study

Active, not recruiting

• Conditions: Obstructive Disease; Atherosclerosis of Popliteal Artery; Atherosclerosis of Femoral Artery
• Interventions: Combination Product: IN.PACT™ Admiral™ Drug Coated Balloon (DCB)

• Registration Number: NCT04597307
• Lead Sponsor: Medtronic

Brief Summary

To prospectively collect and assess the perception of health-related Quality of Life, Pain and Walking Ability.

Detailed Description

To provide both the French National Authority for Health and the French Economic Committee for Health Products requested information on patient-reported outcomes for the IN.PACT™ Admiral™ Drug-Coated Balloon. Patients will be followed using routine clinical practice and the collection of two validated instruments: EuroQOL EQ-5D Quality of Life questionnaire and the Walking Impairment Questionnaire (WIQ).

Study Timeline

• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-22
• Study Start: 2021-02-17
• Primary Completion: 2023-11-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
• Patient has or is intended to receive or be treated with an eligible product
• Patient is consented within the enrollment window of the treatment/therapy received

Exclusion Criteria

• Patient who is, or is expected to be inaccessible for follow-up
• Patient with exclusion criteria required by local law
• Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e. no required intervention that could affect interpretation of all-around product safety and or effectiveness)

Note: For this study, de novo patients will be enrolled to assess EQ-5D and WIQ at baseline and follow-up. Patients cannot be treated in the same procedure with a competitor drug-coated (DCB) or drug-eluting (DES) in the vessel segment treated with IN.PACT Admiral.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IN.PACT™ Admiral™ DCB Cohort	IN.PACT™ Admiral™ Drug Coated Balloon (DCB)	De novo patients not previously treated with a DCB who are successfully treated with the IN.PACT™ Admiral™ DCB (ability to cross the target lesion).

Primary Outcome Measures

Name	Time	Method
Walking Ability Change	Baseline & 12 months after endovascular procedure	Primary Objective: Assess the mean change of patient reported outcomes between pre-procedure visit (baseline) and 12 months after the endovascular procedure of the Walking Impairment Questionnaire (WIQ) (0 to 100% with 100% being better) in the treatment of de novo PTA subjects with obstructive disease of peripheral arteries with the IN.PACT™ Admiral™ DCB.
Quality of Life EQ-5D-5L French Index Score Change	Baseline & 12 months after endovascular procedure	Primary Objective: Assess the mean change of patient reported outcomes between pre-procedure visit (baseline) and 12 months after the endovascular procedure of the EQ-5D-5L Questionnaire using the French Index Score (from -0.530 to 1.000 with 1 being better) in the treatment of de novo PTA subjects with obstructive disease of peripheral arteries with the IN.PACT™ Admiral™ DCB.

Secondary Outcome Measures

Name	Time	Method
Quality of Life EQ-5D-5L French Index Score Change Over Time	Baseline, 30 days, 12 months and 24 months from the endovascular procedure	Assess the mean change of patient reported outcomes over time of EQ-5D-5L French Index Score (from -0.530 to 1.000 with 1 being better) collected at pre-procedure visit (baseline) and at 30 days, 12 months, and 24 months from the endovascular procedure in de novo patients treated with the IN.PACT™ Admiral™ DCB.; In addition, the EQ-5D VAS Score (0 to 100 with 100 being better) will be assessed using the mean change between pre-procedure visit (baseline) and 12 months after endovascular procedure as well as the mean change over time collected at preprocedure visit (baseline) and at 30 days, 12 months, and 24 months from the endovascular procedure with the IN.PACT™ Admiral™ DCB.
Walking Ability Change Over Time	Baseline, 30 days, 12 months and 24 months from the endovascular procedure	Assess the mean change of patient reported outcomes over time of the WIQ composite score (0 to 100% with 100% being better) collected at pre-procedure visit (baseline) and at 30 days, 12 months, and 24 months from the endovascular procedure in de novo patients treated with the IN.PACT™ Admiral™ DCB.; In addition, the WIQ questions for Walking Impairment, Walking Distance, Walking Speed, and Stair Climbing will be assessed using the mean change between pre-procedure visit (baseline) and 12 months after endovascular procedure as well as the mean change over time collected at preprocedure visit (baseline) and at 30 days, 12 months, and 24 months from the endovascular procedure with the IN.PACT™ Admiral™ DCB.

Trial Locations

Locations (9)

Clinique Pasteur; 🇫🇷 Toulouse, France

Hopital Europeen Georges-Pompidou; 🇫🇷 Paris, France

Hopitaux Universitaires de Strasbourg - Nouvel Hopital Civil; 🇫🇷 Strasbourg, France

Centre Hospitalier Clermont-Ferrand-Gabriel-Montpied; 🇫🇷 Clermont-Ferrand, France

Hopitaux Universitaires Paris lle-France Ouest- Hopital Ambroise- Pare; 🇫🇷 Boulogne, France

CHRU Brest Cavale Blanche; 🇫🇷 Brest, France

CHU de Rennes; 🇫🇷 Rennes, France

Clinique Rhena; 🇫🇷 Strasbourg, France

Groupe hospitalier Paris Saint-Joseph; 🇫🇷 Paris, France