Femoropopliteal Atheromatous LesionsDETECTNCT05254106
The DETECT Project
An observational study of Femoropopliteal Atheromatous Lesions, run by Nantes University Hospital at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoropopliteal Atheromatous Lesions
- What is being tested?
- Lower limb artery revascularization with paclitaxel-eluting device
- Type of treatment
- Medical device
- How many people
- 250,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2011to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
CHU Nantes Nantes University Hospital contact
About this study
Official title: The Drug Eluting Devices French Safety Survey
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).
Read the 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.
- Conditions
- Femoropopliteal Atheromatous Lesions
- Being tested
- Lower limb artery revascularization with paclitaxel-eluting device
- Keywords
- Femoropopliteal atheromatous lesions, endovascular revascularization, paclitaxel drug-eluting devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower limb artery revascularization with paclitaxel-eluting deviceDevice
Lower limb artery revascularization with paclitaxel-eluting stent and/or paclitaxel-coated balloon
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Midterm mortality after the procedure of interest
All-cause death
Measured: 2 years
Secondary outcomes (3)
Short-term mortality after the procedure of interest
All-cause death
Measured: 1 year
Long-term mortality after the procedure of interest
All-cause death
Measured: 5 years
Adverse events after the procedure of interest
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.
Measured: 1 year, 2 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Nov 2011
- Primary completion31 Dec 2021
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Femoropopliteal Atheromatous LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- French-Speaking Vascular and Endovascular Surgery Society Support, Boston Scientific Corporation, Cook Research Incorporated
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254106
- Sponsor's protocol ID
- RC20_0067
- Acronym
- DETECT
- Status last verified
- Apr 2022
- First submitted
- 8 Feb 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 38538200
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Drug Eluting Devices French Safety Survey
- ClinicalTrials.gov ID
- NCT05254106
- Acronym / sponsor ID
- DETECT / RC20_0067
- Conditions
- Femoropopliteal Atheromatous Lesions
- Keywords
- Femoropopliteal atheromatous lesions, endovascular revascularization, paclitaxel drug-eluting devices
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250,000 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- French-Speaking Vascular and Endovascular Surgery Society Support, Boston Scientific Corporation, Cook Research Incorporated
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel drug-eluting devices | – | Device: Lower limb artery revascularization with paclitaxel-eluting devicePatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower limb artery revascularization with paclitaxel-eluting deviceLower limb artery revascularization with paclitaxel-eluting stent and/or paclitaxel-coated balloon | Device | Paclitaxel drug-eluting devices |
Primary outcome
Midterm mortality after the procedure of interest
Time frame: 2 years
All-cause death
3 secondary outcomes
Short-term mortality after the procedure of interest
Time frame: 1 year
Long-term mortality after the procedure of interest
Time frame: 5 years
Adverse events after the procedure of interest
Time frame: 1 year, 2 years, 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Derived from this study: PubMed 38538200Wargny 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHU Nantes Nantes University Hospital contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoropopliteal Atheromatous Lesions, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CHU Nantes Nantes University Hospital (bp-prom-regl@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Midterm mortality after the procedure of interest (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05254106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.