Trials / Unknown
UnknownNCT04597307
IN.PACT™ Quality of Life Post-Reimbursement Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 80 (actual)
- Sponsor
- Medtronic · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | IN.PACT™ Admiral™ Drug Coated Balloon (DCB) | For percutaneous transluminal angioplasty (PTA) in subjects with obstructive disease of the peripheral arteries. |
Timeline
- Start date
- 2021-02-17
- Primary completion
- 2023-11-08
- Completion
- 2024-12-01
- First posted
- 2020-10-22
- Last updated
- 2024-03-15
Locations
9 sites across 1 country: France
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04597307. Inclusion in this directory is not an endorsement.