IN.PACT™ Quality of Life Post-Reimbursement Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-17

Study Completion Date

2024-12-31

Brief Summary

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

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Detailed Description

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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).

Conditions

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Obstructive Disease Atherosclerosis of Femoral Artery Atherosclerosis of Popliteal Artery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

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

Intervention Type COMBINATION_PRODUCT

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

Interventions

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

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No