IN.PACT™ Quality of Life Post-Reimbursement Study

Medtronic

Status: Active, not recruiting

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

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

Study type: Observational

Funder types: Industry

Identifiers

NCT04597307

IN.PACT™ QoL PSR

Details and patient eligibility

About

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

Full 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).

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

80 participants in 1 patient group

IN.PACT™ Admiral™ DCB Cohort

Description:

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).

Treatment:

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