IN.PACT™ Quality of Life Post-Reimbursement Study

March 13, 2024 updated by: Medtronic
To prospectively collect and assess the perception of health-related Quality of Life, Pain and Walking Ability.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

80

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

  • France
      • Boulogne, France
        • Hopitaux Universitaires Paris lle-France Ouest- Hopital Ambroise- Pare
      • Brest, France
        • CHRU Brest Cavale Blanche
      • Clermont-Ferrand, France, 63000
        • Centre Hospitalier Clermont-Ferrand-Gabriel-Montpied
      • Paris, France, 75674
        • Groupe Hospitalier Paris Saint-Joseph
      • Paris, France
        • Hôpital Européen Georges-Pompidou
      • Rennes, France
        • CHU de Rennes
      • Strasbourg, France
        • Clinique Rhéna
      • Strasbourg, France
        • Hôpitaux Universitaires de Strasbourg - Nouvel Hôpital Civil
      • Toulouse, France
        • Clinique Pasteur

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

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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).

Description

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 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
For percutaneous transluminal angioplasty (PTA) in subjects with obstructive disease of the peripheral arteries.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life EQ-5D-5L French Index Score Change
Time Frame: 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.
Baseline & 12 months after endovascular procedure
Walking Ability Change
Time Frame: 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.
Baseline & 12 months after endovascular procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life EQ-5D-5L French Index Score Change Over Time
Time Frame: 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.
Baseline, 30 days, 12 months and 24 months from the endovascular procedure
Walking Ability Change Over Time
Time Frame: 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.
Baseline, 30 days, 12 months and 24 months from the endovascular procedure

Collaborators and Investigators

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

Sponsor

Medtronic

Investigators

  • Principal Investigator: Prof. Yann Goueffic, MD, PhD, Hôpital Paris St Joseph

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)

February 17, 2021

Primary Completion (Actual)

November 8, 2023

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 16, 2020

First Submitted That Met QC Criteria

October 20, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IN.PACT™ QoL PSR

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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