IN.PACT™ Quality of Life Post-Reimbursement Study

Atherosclerosis of Femoral Artery Clinical Trial

Official title:

IN.PACT™ Quality of Life Post-Reimbursement Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04597307
• Other study ID #: IN.PACT™ QoL PSR
• Status: Active, not recruiting
• Start date: February 17, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Medtronic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: November 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerosis of Femoral Artery
• Atherosclerosis of Popliteal Artery
• Obstructive Disease

Intervention

Combination Product:
• IN.PACT™ Admiral™ Drug Coated Balloon (DCB)
For percutaneous transluminal angioplasty (PTA) in subjects with obstructive disease of the peripheral arteries.

Locations

Country	Name	City	State
France	Hopitaux Universitaires Paris lle-France Ouest- Hopital Ambroise- Pare	Boulogne
France	CHRU Brest Cavale Blanche	Brest
France	Centre Hospitalier Clermont-Ferrand-Gabriel-Montpied	Clermont-Ferrand
France	Groupe hospitalier Paris Saint-Joseph	Paris
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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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.	Baseline, 30 days, 12 months and 24 months from the endovascular procedure
Secondary	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