AzTrials
AzTrials

Critical Limb IschemiaCLI ENDOVASCNCT04312451

Prospective Cohort of Patients With Critical Limb Ischemia Undergoing Revascularization

An observational study of Critical Limb Ischemia, run by Fondation Hôpital Saint-Joseph at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
Critical Limb Ischemia
How many people
300 participants
Where
1 siteFrance
Study dates
5 Nov 2021to 25 Jun 2027
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

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 are hospitalized in the vascular medicine department of the Paris Saint-Joseph Hospital Group, for the management of critical ischemia of the lower limbs with decision to revascularize by endovascular route for leg rescue, after discussion in multidisciplinary staff (associating vascular physicians, vascular surgeons and interventional radiologists).

Who may be able to join

  • Man or Woman whose age is ≥ 18 years old
  • Patient with critical lower limb ischemia defined by the existence of decubitus pain or a wound (foot ulcer or gangrene) evolving for more than 2 weeks associated with hemodynamic criteria (systolic toe pressure <30 mm Hg and / or systolic ankle pressure <50 mm Hg).
  • Hospitalized in the vascular medicine department
  • Endovascular revascularization gesture discussed and confirmed by multidisciplinary staff

Who cannot join

  • Patients under guardianship or curatorship
  • Patients deprived of their liberty
  • Patients objecting to the use of their data for this research

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alexandra YANNOUTSOS, MD contact

144123568 ext. +33

ayannoutsos@hpsj.fr

Helene BEAUSSIER, PharmD, pHD contact

144127038 ext. +33

crc@hpsj.fr

France1 site, 1 recruiting

  • Groupe Hospitalier Paris Saint-Joseph

    Paris, 75014

    Alexandra YANNOUTSOS, MD

    Helene BEAUSSIER, pharmD, pHD

    Recruiting

Other trials in France

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 prospective study is to assess the vital prognosis, limb salvage and associated prognostic factors in patients with critical ischemia supported by endovascular revascularization in the vascular medicine service of the GHPSJ. The objective of this cohort study is to build a database on critical ischemia in hospitalized patients, to judge the management, monitoring and prognosis of patients.

Medical subject headings
Chronic Limb-Threatening Ischemia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival rate without major amputation

    This outcome measure the survival rate without major amputation at 1 year.

    Measured: Year 1

Secondary outcomes (5)

  1. Prevalence of intraoperative deaths

    This outcome measures the prevalence of intraoperative deaths.

    Measured: Day 1

  2. Prevalence of intraoperative cardiovascular events

    This outcome measures the prevalence of intraoperative cardiovascular events.

    Measured: Day 1

  3. Prevalence of intraoperative deaths, at 1 year

    This outcome measures the prevalence of intraoperative deaths, at 1 year after the surgery.

    Measured: Year 1

  4. Prevalence of intraoperative cardiovascular events, at 1 year

    This outcome measures the prevalence of intraoperative cardiovascular events at 1 year after the surgery.

    Measured: Year 1

  5. Healing rate

    This outcome measures 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.

  1. First posted18 Mar 2020
  2. Study start5 Nov 2021
  3. Primary completion25 Jun 2026 (estimated)
  4. Study completion25 Jun 2027 (estimated)

Resources

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
300 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT04312451
Sponsor's protocol ID
CLI ENDOVASC
Acronym
CLI ENDOVASC
Status last verified
Sep 2022
First submitted
16 Mar 2020
Last updated
3 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Savji N, Rockman CB, Skolnick AH, Guo Y, Adelman MA, Riles T, Berger JS. Association between advanced age and vascular disease in different arterial territories: a population database of over 3.6 million subjects. J Am Coll Cardiol. 2013 Apr 23;61(16):1736-43. doi: 10.1016/j.jacc.2013.01.054. Epub 2013 Apr 2.

    PubMed 23500290

  • Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015 Apr 24;116(9):1509-26. doi: 10.1161/CIRCRESAHA.116.303849.

    PubMed 25908725

  • Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007 Jan;45 Suppl S:S5-67. doi: 10.1016/j.jvs.2006.12.037. No abstract available.

    PubMed 17223489

  • Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I, Document Reviewers, Widimsky P, Kolh P, Agewall S, Bueno H, Coca A, De Borst GJ, Delgado V, Dick F, Erol C, Ferrini M, Kakkos S, Katus HA, Knuuti J, Lindholt J, Mattle H, Pieniazek P, Piepoli MF, Scheinert D, Sievert H, Simpson I, Sulzenko J, Tamargo J, Tokgozoglu L, Torbicki A, Tsakountakis N, Tunon J, Vega de Ceniga M, Windecker S, Zamorano JL. Editor's Choice - 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg. 2018 Mar;55(3):305-368. doi: 10.1016/j.ejvs.2017.07.018. Epub 2017 Aug 26. No abstract available.

    PubMed 28851596

  • Romiti M, Albers M, Brochado-Neto FC, Durazzo AE, Pereira CA, De Luccia N. Meta-analysis of infrapopliteal angioplasty for chronic critical limb ischemia. J Vasc Surg. 2008 May;47(5):975-981. doi: 10.1016/j.jvs.2008.01.005. Epub 2008 Apr 18.

    PubMed 18372148

  • Salas CA, Adam DJ, Papavassiliou VG, London NJ. Percutaneous transluminal angioplasty for critical limb ischaemia in octogenarians and nonagenarians. Eur J Vasc Endovasc Surg. 2004 Aug;28(2):142-5. doi: 10.1016/j.ejvs.2004.03.023.

    PubMed 15234694

  • Faglia E, Mantero M, Caminiti M, Caravaggi C, De Giglio R, Pritelli C, Clerici G, Fratino P, De Cata P, Dalla Paola L, Mariani G, Poli M, Settembrini PG, Sciangula L, Morabito A, Graziani L. Extensive use of peripheral angioplasty, particularly infrapopliteal, in the treatment of ischaemic diabetic foot ulcers: clinical results of a multicentric study of 221 consecutive diabetic subjects. J Intern Med. 2002 Sep;252(3):225-32. doi: 10.1046/j.1365-2796.2002.01015.x.

    PubMed 12270002

Questions about this trial

What is this clinical trial studying?

An observational study of Critical Limb Ischemia, 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: looking for participants now, as of the sponsor's last update on 3 Oct 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alexandra YANNOUTSOS, MD (144123568 ext. +33, ayannoutsos@hpsj.fr), or a site near the patient. 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 NCT04312451, which also lists 7 linked publications.

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 3 Oct 2022.

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