Peripheral Arterial DiseaseNCT05155462
Analysis of the Different Strategies for Revascularization of the Lower Limbs by Peripheral Angioplasty
An observational study of Peripheral Arterial Disease and Angioplasty, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Peripheral arterial disease (PAD) caused by atherosclerosis causes damage to the arteries originating in the aorta (descending) from the iliacs to the extremities of the lower limbs. It causes significant morbidity and mortality. Percutaneous revascularization plays a key role in the management of these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Angioplasty
- What is being tested?
- One or two phone call
- How many people
- 330 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2019to 9 Dec 2021
- 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: Patient 18 or over, treated for symptomatic chronic ischemia of the lower limbs defined by Rutherford categories 2-4 and / or Leriche stage greater than 2a
Who may be able to join
- Patient treated by the peripheral angioplasty department of Claude Galien Hospital from January 2010 and with at least 1 year of follow-up after the revascularization procedure
- Patient treated for symptomatic chronic ischemia of the lower limbs defined by Rutherford categories 2-4 and / or Leriche stage greater than 2a
- Stenosis or restenosis (history of balloon angioplasty, active balloon or bare stent)
- Degree of stenosis ≥ 50% by angiographic evaluation visual, by CT scan or by Doppler ultrasound
- Patient affiliated or beneficiary of a social security scheme
- Patient aged 18 or over
- Patient having been informed and not opposing this research
Who cannot join
- Medical history of myocardial infarction or stroke within 3 months of the revascularization procedure
- Unstable angina at the time of the revascularization procedure
- Sepsis at the time of the revascularization procedure
- Major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Hospitalized without consent
- Pregnant, breastfeeding or parturient woman
Trial locations and contacts
1 site in 1 country.
Marie-Hélène Barba contact
France1 site, 1 recruiting
- Recruiting
Hôpital Privé Claude Galien
Quincy-sous-Sénart, 91480
Thierry UNTERSEEH, Dr, 06.25.08.79.77, t.unterseeh@icps.com.fr
About this study
Peripheral arterial disease (PAD) caused by atherosclerosis causes damage to the arteries originating in the aorta (descending) from the iliacs to the extremities of the lower limbs. It causes significant morbidity and mortality. Percutaneous revascularization plays a key role in the management of these patients. Many percutaneous treatment options have been developed: arteriectomy, naked stents, active balloons and active stents. Of these, only paclitaxel-active stents were successful in reducing the rates of restenosis and reoperation in patients with superficial femoral artery injury.The main objective is to study symptomatic improvement at 1 year of patients treated with revascularization of the lower limbs.
- Conditions
- Peripheral Arterial Disease, Angioplasty
- Being tested
- One or two phone call
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One or two phone callOther
Phone call to collect patient data
| Study group | Role | What they receive |
|---|---|---|
| Patient treated for defined symptomatic chronic lower extremity ischemia | Not described Receives: Other: One or two phone call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic improvement will be assessed by the evolution of the Leriche and Rutherford classifications before the revascularization procedure and 1 year after the revascularization procedure
Lerich classification : stage I to IV Rutherford : stage 0 to 6
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start9 Apr 2019
- Primary completion9 Apr 2020
- Study completion9 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155462
- Sponsor's protocol ID
- 2018-A00868-47
- Status last verified
- Nov 2021
- First submitted
- 30 Nov 2021
- Last updated
- 13 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Different Strategies for Revascularization of the Lower Limbs by Peripheral Angioplasty
- ClinicalTrials.gov ID
- NCT05155462
- Acronym / sponsor ID
- 2018-A00868-47
- Conditions
- Peripheral Arterial Disease, Angioplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 9 Apr 2020 (actual)
- Study completion
- 9 Dec 2021 (estimated)
- First posted
- 13 Dec 2021 (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 disease (PAD) caused by atherosclerosis causes damage to the arteries originating in the aorta (descending) from the iliacs to the extremities of the lower limbs. It causes significant morbidity and mortality. Percutaneous revascularization plays a key role in the management of these patients. Many percutaneous treatment options have been developed: arteriectomy, naked stents, active balloons and active stents. Of these, only paclitaxel-active stents were successful in reducing the rates of restenosis and reoperation in patients with superficial femoral artery injury.The main objective is to study symptomatic improvement at 1 year of patients treated with revascularization of the lower limbs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient treated for defined symptomatic chronic lower extremity ischemia | – | Other: One or two phone call |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient 18 or over, treated for symptomatic chronic ischemia of the lower limbs defined by Rutherford categories 2-4 and / or Leriche stage greater than 2a
Key inclusion criteria (7 listed)
- Patient treated by the peripheral angioplasty department of Claude Galien Hospital from January 2010 and with at least 1 year of follow-up after the revascularization procedure
- Patient treated for symptomatic chronic ischemia of the lower limbs defined by Rutherford categories 2-4 and / or Leriche stage greater than 2a
- Stenosis or restenosis (history of balloon angioplasty, active balloon or bare stent)
- Degree of stenosis ≥ 50% by angiographic evaluation visual, by CT scan or by Doppler ultrasound
- Patient affiliated or beneficiary of a social security scheme
Key exclusion criteria (6 listed)
- Medical history of myocardial infarction or stroke within 3 months of the revascularization procedure
- Unstable angina at the time of the revascularization procedure
- Sepsis at the time of the revascularization procedure
- Major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Hospitalized without consent
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 |
|---|---|---|
| One or two phone callPhone call to collect patient data | Other | Patient treated for defined symptomatic chronic lower extremity ischemia |
Primary outcome
Symptomatic improvement will be assessed by the evolution of the Leriche and Rutherford classifications before the revascularization procedure and 1 year after the revascularization procedure
Time frame: 1 year
Lerich classification : stage I to IV Rutherford : stage 0 to 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
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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.
Marie-Hélène Barba 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 Peripheral Arterial Disease and Angioplasty, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 7 inclusion and 6 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 13 Dec 2021. 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 Jean-François Oudet (0683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic improvement will be assessed by the evolution of the Leriche and Rutherford classifications before the revascularization procedure and 1 year after the revascularization procedure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2021.