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The DETECT Project (DETECT)

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ClinicalTrials.gov Identifier: NCT05254106
Recruitment Status : Recruiting
First Posted : February 24, 2022
Last Update Posted : April 28, 2022
Sponsor:
Collaborators:
French-Speaking Vascular and Endovascular Surgery Society Support
Boston Scientific Corporation
Cook Research Incorporated
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
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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).

Condition or disease Intervention/treatment
Femoropopliteal Atheromatous Lesions Device: Lower limb artery revascularization with paclitaxel-eluting device

Detailed Description:

Endovascular intervention is considered as a first-line treatment for femoropopliteal atheromatous lesions. During the 2000s, the superiority of auto-expandable stent compared to percutaneous transluminal angioplasty had been demonstrated, in terms of effectiveness. Over the past decade, paclitaxel drug-eluting balloons or stents were successfully assessed in order to prevent intimal hyperplasia and to treat restenosis.

Nevertheless, in 2018, Katsanos and al. reported in a meta-analysis a higher risk of death at 2 and 5 years for patients treated by a paclitaxel drug-eluting balloons or stents versus non-drug-eluting devices. This study presents many limitations despite being performed as a systematic review of randomized clinical trials. Since then, several studies have been conducted without any statistical trends in favor of a higher mortality in patients treated by drug-eluting stents or drug-coated balloons.

Analysis based on US or Germany databases in tens of thousands of patients has been published but individual data were unavailable. In France, there is no national report about the safety of paclitaxel drug-eluting devices prescribed in the case of endovascular femoropopliteal artery treatment. Therefore, this study aims to compare the risk of all-cause death of patients treated by paclitaxel-eluting devices versus non-drug-eluting devices in this indication at a national-scale using real-life data from SNDS.

This analysis of the SNDS database will allow (i) to identify all patients across France treated by endovascular intervention for a femoropopliteal revascularization and to know precisely the medical device used; (ii) to reduce confusion bias based on the characterization of patients thanks to their data of medical follow-up, treatment, hospitalization and LTD (long-term condition); (iii) to document their care pathway, especially drugs delivery and diagnosis associated to possible hospitalization, or to all-cause death, in order to compare the 1-, 2- and 5-years prognosis according to the medical device used.

Study Design
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Study Type : Observational
Estimated Enrollment : 250000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Drug Eluting Devices French Safety Survey
Actual Study Start Date : November 1, 2011
Actual Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
Lower limb artery revascularization with paclitaxel-eluting stent and/or paclitaxel-coated balloon
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.


Outcome Measures
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Primary Outcome Measures :
  1. Midterm mortality after the procedure of interest [ Time Frame: 2 years ]
    All-cause death


Secondary Outcome Measures :
  1. Short-term mortality after the procedure of interest [ Time Frame: 1 year ]
    All-cause death

  2. Long-term mortality after the procedure of interest [ Time Frame: 5 years ]
    All-cause death

  3. Adverse events after the procedure of interest [ Time Frame: 1 year, 2 years, 5 years ]
    Hospitalization for coronary artery disease (myocardial infarction or coronary revascularization), cerebrovascular accident, transient ischemic attack, lower limb amputation (minor and major), a major adverse cardiovascular event (define as the composite of death, myocardial infarction, cerebrovascular accident, transient ischemic attack, major amputation), a major adverse limb event (define as the composite of a lower limb revascularization or a major amputation) or all-cause mortality.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05254106


Contacts
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Contact: CHU Nantes Nantes University Hospital bp-prom-regl@chu-nantes.fr

Locations
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France
France Recruiting
Whole Country, France
Sponsors and Collaborators
Nantes University Hospital
French-Speaking Vascular and Endovascular Surgery Society Support
Boston Scientific Corporation
Cook Research Incorporated
  Study Documents (Full-Text)

Documents provided by Nantes University Hospital:
Statistical Analysis Plan  [PDF] February 2, 2022

More Information
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT05254106    
Other Study ID Numbers: RC20_0067
First Posted: February 24, 2022    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Nantes University Hospital:
Femoropopliteal atheromatous lesions
endovascular revascularization
paclitaxel drug-eluting devices
Additional relevant MeSH terms:
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Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action