Atherosclerosis of Femoral Artery, Atherosclerosis of Popliteal Artery, Obstructive Disease
Conditions
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).
Interventions
COMBINATION_PRODUCTIN.PACT™ Admiral™ Drug Coated Balloon (DCB)
For percutaneous transluminal angioplasty (PTA) in subjects with obstructive disease of the peripheral arteries.
Sponsors
Medtronic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life EQ-5D-5L French Index Score Change | 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. |
| Walking Ability Change | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life EQ-5D-5L French Index Score Change Over Time | 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. |
| Walking Ability Change Over Time | 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. |
Countries
France
Outcome results
None listed