Clinical trial NCT04597307: IN.PACT™ Quality of Life Post-Reimbursement Study
Official title: IN.PACT™ Quality of Life Post-Reimbursement Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obstructive Disease
Atherosclerosis of Femoral Artery
Atherosclerosis of Popliteal Artery
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2020-10-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Life EQ-5D-5L French Index Score Change
timeFrame: Baseline & 12 months after endovascular procedure
measure: Walking Ability Change
timeFrame: Baseline & 12 months after endovascular procedure
Secondary outcomes:
measure: Quality of Life EQ-5D-5L French Index Score Change Over Time
timeFrame: Baseline, 30 days, 12 months and 24 months from the endovascular procedure
measure: Walking Ability Change Over Time
timeFrame: Baseline, 30 days, 12 months and 24 months from the endovascular procedure
Other outcomes:
Locations:
city: Boulogne
country: France
facility: Hopitaux Universitaires Paris lle-France Ouest- Hopital Ambroise- Pare
city: Brest
country: France
facility: CHRU Brest Cavale Blanche
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Clermont-Ferrand-Gabriel-Montpied
city: Paris
country: France
facility: Groupe hospitalier Paris Saint-Joseph
city: Paris
country: France
facility: Hopital Europeen Georges-Pompidou
city: Rennes
country: France
facility: CHU de Rennes
city: Strasbourg
country: France
facility: Clinique Rhena
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg - Nouvel Hopital Civil
city: Toulouse
country: France
facility: Clinique Pasteur
Study officials:
affiliation: Hôpital Paris St Joseph
name: Prof. Yann Goueffic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: