The DETECT Project

NCT05254106 | Unknown FDA Device

• 1 other identifier: RC20_0067
• Study Type: observational
• Target: 250,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the all-cause mortality at 2 years of patients treated by a paclitaxel drug-eluting devices or non-drug-eluting devices after an endovascular femoropopliteal artery revascularization based on the French National Healthcare Data System (SNDS).

Conditions

Femoropopliteal Atheromatous Lesions

Keywords

Femoropopliteal atheromatous lesions; endovascular revascularization; paclitaxel drug-eluting devices

Outcome Measures

Primary Outcomes (1)

• Midterm mortality after the procedure of interest

  All-cause death

  2 years

Secondary Outcomes (3)

• Short-term mortality after the procedure of interest

  1 year

• Long-term mortality after the procedure of interest

  5 years

• Adverse events after the procedure of interest

  1 year, 2 years, 5 years

Study Arms (2)

Paclitaxel drug-eluting devices

Patients treated by at least one paclitaxel drug-eluting balloon or stent after an endovascular femoropopliteal artery revascularization between October 2011 and December 2019 in France.

Device: Lower limb artery revascularization with paclitaxel-eluting device

Non-drug-eluting devices

Patients exclusively treated by a non-drug-eluting balloon or stent after an endovascular femoropopliteal artery revascularization between October 2011 and December 2019 in France.

Interventions

Lower limb artery revascularization with paclitaxel-eluting device DEVICE

Lower limb artery revascularization with paclitaxel-eluting stent and/or paclitaxel-coated balloon

Paclitaxel drug-eluting devices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients included in this study were all patients identified in SNDS with an endovascular femoropopliteal artery intervention by non-drug-eluting balloon/stent or paclitaxel drug-eluting balloon/stent between October 2011 and December 2019 in France.

You may qualify if:

• age ≥ 18 years old on day of hospital admission for the hereafter related surgical procedure
• Affiliated member to the French Social Security system
• Admitted in a French hospital, public or private, between October 2011 and December 2019
• Benefitting from an endovascular femoropopliteal surgical procedure coded with ≥ 1 of the 9 codes of the Common Classification of Medical Procedures (EEAF001, EEAF002, EEAF003, EEAF004, EEAF005, EEAF006, EEPF001, EEPF002, EELF002)
• Associated to the reimbursement by the health insurance scheme for one device of interest cited in the SAP (statistical analyses plan)

Sponsors & Collaborators

• Nantes University Hospital: lead
• French-Speaking Vascular and Endovascular Surgery Society Support: collaborator
• Boston Scientific Corporation: collaborator
• Cook Research Incorporated: collaborator

Study Sites (1)

France

Whole Country, France

RECRUITING

Related Publications (1)

• Wargny M, Leux C, Chatellier G, Coudol S, Gourraud PA, Goueffic Y. Mortality in a Nationwide Practice-Based Cohort Receiving Paclitaxel-Coated Devices for Lower Limb Peripheral Artery Disease. J Am Coll Cardiol. 2024 Apr 2;83(13):1207-1221. doi: 10.1016/j.jacc.2024.02.003. Epub 2024 Mar 25.

  PMID: 38538200 DERIVED

Central Study Contacts

CHU Nantes Nantes University Hospital

CONTACT

bp-prom-regl@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 24, 2022
• Study Start: November 1, 2011
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2024
• Last Updated: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)