Peripheral Arterial Obstructive DiseaseEndoRevINCT04114838
Cohort Study of Patients Treated for Peripheral Arterial Occlusive Disease
An observational study of Peripheral Arterial Obstructive Disease, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Peripheral Arterial Occlusive Disease is associated with a high risk of cardiovascular events. The critical ischemia stage represents the most severe stage of Peripheral Arterial Occlusive Disease, associated with decubitus pain and / or foot ulceration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Obstructive Disease
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2020to 6 May 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients were hospitalized the vascular medicine department of the Hospital Group Paris Saint-Joseph, for management of an PAOD with endovascular revascularization, between November 1, 2013 and September 2018.
Who may be able to join
- Patient whose age ≥ 18 years
- Patient with intermittent / intermittent claudication / arterial ulcer / mixed ulcer / critical ischemia / acute ischemia, whose need for a revascularization procedure in the patient's medical management was discussed and confirmed as a multidisciplinary staff between 1st November 2013 and September 2018
- endovascular revascularized Patient
- Francophone patients
Who cannot join
- Patients under guardianship or curatorship
- Patients deprived of their liberty
- Patients who oppose the use of their data for this research
Trial locations and contacts
1 site in 1 country.
About this study
Peripheral Arterial Occlusive Disease is associated with a high risk of cardiovascular events. The critical ischemia stage represents the most severe stage of Peripheral Arterial Occlusive Disease, associated with decubitus pain and / or foot ulceration. The severity of this arterial involvement involves functional prognosis of the lower limb with a high risk of amputation, and the vital prognosis of the patient. In these patients, the rate of amputation and mortality at 1 year can reach 20%. Therefore, the goal of management in a multidisciplinary setting is limb salvage and improvement of the patient's vital prognosis.
In the vascular medicine department, the indication and modalities of the revascularization procedure are discussed in a multidisciplinary consultation meeting. Surgical revascularization by distal bypass requires venous material that can be used, a receiving artery without diffuse lesions, in direct continuity with the arterial network of the foot, and the absence of co-morbidities against general anesthesia. With the modernization and development of endovascular equipment dedicated to the hamstrings, the interventional radiology techniques in the management of critical ischemia allow the treatment of one or more arterial axes as well as a very distal revascularization in the arteries. of the foot with less morbidity-mortality compared to surgery, especially in patients the most fragile patients. Since 2013, the endovascular revascularization procedures performed by the interventional radiology team have been an integral part of the management of patients with peripheral arterial disease of the lower limbs monitored in the vascular medicine department. The hospital is therefore a privileged place to observe the long-term impact of this medical care on the future of patients with different stages of severity of arterial disease.
The objective of this retrospective study is to evaluate the life-threatening, limb salvage and associated prognostic factors in patients with Peripheral Arterial Occlusive Disease supported by endovascular revascularization in the vascular medicine department of the GHPSJ.
- Conditions
- Peripheral Arterial Obstructive Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate without major amputation
The outcome measure the survival rate without major amputation at 1 year.
Measured: year 1
Secondary outcomes (4)
Prevalence of Intraoperative Deaths and Cardiovascular Events
This measures the prevalence of Intraoperative Deaths and Cardiovascular Events.
Measured: Day 1
Prevalence of Deaths and Cardiovascular Events, at 1 month
This measures the prevalence of Deaths and Cardiovascular Events, 1 month after the surgery.
Measured: Month 1
Prevalence of Deaths and Cardiovascular Events, at 1 year
This measures the prevalence of Deaths and Cardiovascular Events, 1 year after the surgery.
Measured: Year 1
Healing rate
This outcome measure the healing rate, 1 year after the surgery.
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start2 Jan 2020
- Primary completion30 Mar 2021
- Study completion6 May 2022
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 Peripheral Arterial Obstructive DiseaseStudies 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra YANNOUTSOS, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114838
- Sponsor's protocol ID
- EndoRevI
- Acronym
- EndoRevI
- Status last verified
- May 2022
- First submitted
- 2 Oct 2019
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yannoutsos A, Lin F, Billuart O, Gaisset R, Sacco E, Beaussier H, Buronfosse A, Mourad JJ, Emmerich J, Lazareth I, Priollet P. Predictive value of admission blood pressure for 3-month mortality in patients undergoing revascularization for critical limb ischemia. J Hypertens. 2020 Dec;38(12):2409-2415. doi: 10.1097/HJH.0000000000002556.
PubMed 32694333
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Patients Treated for Peripheral Arterial Occlusive Disease
- ClinicalTrials.gov ID
- NCT04114838
- Acronym / sponsor ID
- EndoRevI / EndoRevI
- Conditions
- Peripheral Arterial Obstructive Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 3 Oct 2019 (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.
Peripheral Arterial Occlusive Disease is associated with a high risk of cardiovascular events. The critical ischemia stage represents the most severe stage of Peripheral Arterial Occlusive Disease, associated with decubitus pain and / or foot ulceration. The severity of this arterial involvement involves functional prognosis of the lower limb with a high risk of amputation, and the vital prognosis of the patient. In these patients, the rate of amputation and mortality at 1 year can reach 20%. Therefore, the goal of management in a multidisciplinary setting is limb salvage and improvement of the patient's vital prognosis.
In the vascular medicine department, the indication and modalities of the revascularization procedure are discussed in a multidisciplinary consultation meeting. Surgical revascularization by distal bypass requires venous material that can be used, a receiving artery without diffuse lesions, in direct continuity with the arterial network of the foot, and the absence of co-morbidities against general anesthesia. With the modernization and development of endovascular equipment dedicated to the hamstrings, the interventional radiology techniques in the management of critical ischemia allow the treatment of one or more arterial axes as well as a very distal revascularization in the arteries. of the foot with less morbidity-mortality compared to surgery, especially in patients the most fragile patients. Since 2013, the endovascular revascularization procedures performed by the interventional radiology team have been an integral part of the management of patients with peripheral arterial disease of the lower limbs monitored in the vascular medicine department. The hospital is therefore a privileged place to observe the long-term impact of this medical care on the future of patients with different stages of severity of arterial disease.
The objective of this retrospective study is to evaluate the life-threatening, limb salvage and associated prognostic factors in patients with Peripheral Arterial Occlusive Disease supported by endovascular revascularization in the vascular medicine department of the GHPSJ.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were hospitalized the vascular medicine department of the Hospital Group Paris Saint-Joseph, for management of an PAOD with endovascular revascularization, between November 1, 2013 and September 2018.
Key inclusion criteria (4 listed)
- Patient whose age ≥ 18 years
- Patient with intermittent / intermittent claudication / arterial ulcer / mixed ulcer / critical ischemia / acute ischemia, whose need for a revascularization procedure in the patient's medical management was discussed and confirmed as a multidisciplinary staff between 1st November 2013 and September 2018
- endovascular revascularized Patient
- Francophone patients
Key exclusion criteria (3 listed)
- Patients under guardianship or curatorship
- Patients deprived of their liberty
- Patients who oppose the use of their data for this research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival rate without major amputation
Time frame: year 1
The outcome measure the survival rate without major amputation at 1 year.
4 secondary outcomes
Prevalence of Intraoperative Deaths and Cardiovascular Events
Time frame: Day 1
Prevalence of Deaths and Cardiovascular Events, at 1 month
Time frame: Month 1
Prevalence of Deaths and Cardiovascular Events, at 1 year
Time frame: Year 1
Healing rate
Time frame: Year 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Results publication: PubMed 32694333Yannoutsos A, Lin F, Billuart O, Gaisset R, Sacco E, Beaussier H, Buronfosse A, Mourad JJ, Emmerich J, Lazareth I, Priollet P. Predictive value of admission blood pressure for 3-month mortality in patients undergoing revascularization for critical limb ischemia. J Hypertens. 2020 Dec;38(12):2409-2415. doi: 10.1097/HJH.0000000000002556.
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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.
Alexandra YANNOUTSOS, MD principal investigator
Fondation Hôpital Saint-Joseph
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 Peripheral Arterial Obstructive Disease, run by Fondation Hôpital Saint-Joseph 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 11 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate without major amputation (time frame: year 1). 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 NCT04114838, 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 11 May 2022.