Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To prospectively collect and assess the perception of health-related Quality of Life, Pain and Walking Ability.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IN.PACT™ Admiral™ Drug Coated Balloon (DCB) | Combination Product | For percutaneous transluminal angioplasty (PTA) in subjects with obstructive disease of the peripheral arteries. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life EQ-5D-5L French Index Score Change | 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. | Baseline & 12 months after endovascular procedure |
| Walking Ability Change | 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. | Baseline & 12 months after endovascular procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life EQ-5D-5L French Index Score Change Over Time | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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.
Not provided
Not provided
Not provided
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).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Prof. Yann Goueffic, MD, PhD | Hôpital Paris St Joseph | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopitaux Universitaires Paris lle-France Ouest- Hopital Ambroise- Pare | Boulogne | France | ||||
| CHRU Brest Cavale Blanche |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline, 30 days, 12 months and 24 months from the endovascular procedure |
| Walking Ability Change Over Time | 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. | Baseline, 30 days, 12 months and 24 months from the endovascular procedure |
| Brest |
| France |
| Centre Hospitalier Clermont-Ferrand-Gabriel-Montpied | Clermont-Ferrand | 63000 | France |
| Groupe hospitalier Paris Saint-Joseph | Paris | 75674 | France |
| Hopital Europeen Georges-Pompidou | Paris | France |
| CHU de Rennes | Rennes | France |
| Clinique Rhena | Strasbourg | France |
| Hopitaux Universitaires de Strasbourg - Nouvel Hopital Civil | Strasbourg | France |
| Clinique Pasteur | Toulouse | France |