IN.PACT™ Quality of Life Post-Reimbursement Study

NCT04597307 | Active Not Recruiting FDA Device

• 1 other identifier: IN.PACT™ QoL PSR
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Obstructive Disease; Atherosclerosis of Femoral Artery; Atherosclerosis of Popliteal Artery

Outcome Measures

Primary Outcomes (2)

• Quality of Life EQ-5D-5L French Index Score Change

  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.

  Baseline & 12 months after endovascular procedure

• Walking Ability Change

  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.

  Baseline & 12 months after endovascular procedure

Secondary Outcomes (2)

• Quality of Life EQ-5D-5L French Index Score Change Over Time

  Baseline, 30 days, 12 months and 24 months from the endovascular procedure

• Walking Ability Change Over Time

  Baseline, 30 days, 12 months and 24 months from the endovascular procedure

Study Arms (1)

IN.PACT™ Admiral™ DCB Cohort

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).

Combination Product: IN.PACT™ Admiral™ Drug Coated Balloon (DCB)

Interventions

IN.PACT™ Admiral™ Drug Coated Balloon (DCB) COMBINATION_PRODUCT

For percutaneous transluminal angioplasty (PTA) in subjects with obstructive disease of the peripheral arteries.

IN.PACT™ Admiral™ DCB Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes patients with obstructive disease of the peripheral arteries that will have a percutaneous transluminal angioplasty (PTA) with the IN.PACT™ Admiral™ Drug Coated Balloon (DCB).

You may qualify if:

• 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

You may not qualify if:

• Patient who is, or is expected to be inaccessible for follow-up
• 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.

Sponsors & Collaborators

• Medtronic: lead

Study Sites (9)

Hopitaux Universitaires Paris lle-France Ouest- Hopital Ambroise- Pare

Boulogne, France

Location

CHRU Brest Cavale Blanche

Brest, France

Location

Centre Hospitalier Clermont-Ferrand-Gabriel-Montpied

Clermont-Ferrand, 63000, France

Location

Groupe hospitalier Paris Saint-Joseph

Paris, 75674, France

Location

Hopital Europeen Georges-Pompidou

Paris, France

Location

CHU de Rennes

Rennes, France

Location

Clinique Rhena

Strasbourg, France

Location

Hopitaux Universitaires de Strasbourg - Nouvel Hopital Civil

Strasbourg, France

Location

Clinique Pasteur

Toulouse, France

Location

Study Officials

• Prof. Yann Goueffic, MD, PhD

  Hôpital Paris St Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: October 22, 2020
• Study Start: February 17, 2021
• Primary Completion: November 8, 2023
• Study Completion: December 1, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)