Evaluation of Acute Lower Limb Ischemia (PROMOTE-ALI)

October 30, 2023 updated by: Medical University Innsbruck

Prospective Multicenter Observational Study Evaluating Acute Lower Limb Ischemia

The primary objective of this study is to evaluate the effect of different treatment modalities on clinical outcome of patients suffering from acute lower limb ischemia (ALI). Depending on clinical presentation, anatomical as well as technical considerations, different treatment options are available for revascularisation of affected limbs. Using an observational, international, multicentric study design (min. patient number of 500), the defined primary endpoint of the study, amputation-free survival 90 days after the diagnosis of ALI, will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recently published clinical guidelines highlighted that the available evidence on the management of acute lower limb ischemia (ALI) is mostly outdated and includes only small patient cohorts. Depending on the patient's characteristics, the duration of ischemic symptoms as well as the cause of ALI and the anatomical lesion, different treatment options are available and need to be compared regarding clinical outcome.

With the knowledge about the heterogeneity of patients suffering from ALI, a multicentre observational study design has the potential to give results on influence of several factors (patient related factors, treatment related factors) on clinical outcome of patients with lower extremity ALI. In contrast, a randomized controlled trial would not be feasible as heterogeneity of patients would lead to limitations in the recruitment of patients.

The primary objective of this study is to evaluate the effect of different treatment modalities on clinical outcome of patients suffering from acutle lower limb ischemia. Depending on clinical presentation, anatomical as well as technical considerations, different treatment options are available for revascularisation of affected limbs. Using an observational, international, multicentric study design (min. patient number of 500), the defined primary endpoint of the study, amputation-free survival 90 days after the diagnosis of ALI, will be evaluated.

The secondary objectives of this study are the identification of factors having an effect on the primary endpoint . These factors are:

  • Demographic data (age, gender, Body Mass Index,
  • Cardiovascular risk factors (diabetes, arterial hypertension, dyslipidemia, smoking history)
  • COVID-19 anamnesis (infectious status; vaccination status)
  • Pre-existing diseases (Arterial fibrillation, chronic kidney disease, hemodialysis, coronary artery disease, COVID infection in medical history, pulmonary disease)
  • Risk factors for ALI (peripheral arterial disease, aortic aneurysm or dissection, arterial embolization in medical history, malignant disease, peripheral arterial aneurysm, previous stroke, thrombophilia, revascularization procedure on ipsilateral limb)
  • Pre-existing medication (antiplatelet, oral anticoagulation, statins)
  • Clinical presentation (Rutherford ischemia classification, Cause of ALI, anatomical level of arterial occlusion, diagnostic imaging modality)
  • Details on performed intervention (time of ischemia, periprocedural heparin administration, type of procedure, technical details on performed procedure, compartment syndrome with need for fasciotomy)
  • Outcome parameters (Survival, Rutherford ischemia classification, residual sensory or motor deficit, impaired walking distance, need for reintervention, major bleeding periprocedural, access site complications, organ failure) 30 and 90 days after diagnosis of ALI.

Study Type

Observational

Enrollment (Actual)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Medical University of Innsbruck, Department of Vascular Surgery
      • Vienna, Austria, 1090
        • Department of General Surgery, Division of Vascular Surgery, Medical University of Vienna
      • Vienna, Austria, 1160
        • Department of Vascular and Endovascular Surgery, Hospital Ottakring
      • Vienna, Austria, 1210
        • Department of Cardio-Vascular Surgery, Clinic Floridsdorf and Karl Landsteiner Institute for Cardio-Vascular Research
  • Croatia
      • Zagreb, Croatia, 10000
        • University Hospital Merkur
  • France
      • Antibes, France
        • Department of Vascular Surgery, Hospital of Antibes Juan-les-Pins
      • Bordeaux, France
        • Department of Vascular Surgery, Bordeaux University Hospital
      • Boulogne-Billancourt, France, 92100
        • Department of Vascular Surgery, Ambroise Paré University Hospital, Assistance Publique-Hôpitaux de Paris
      • Brest, France
        • Department of Vascular and Endovascular Surgery, Brest University Hospital
      • Créteil, France
        • Department of Vascular Surgery, Henri Mondor University Hospital
      • Dijon, France
        • Department of Vascular Surgery, University Hospital of Dijon
      • Lyon, France
        • Vascular Surgery Department, Hospices Civils de Lyon
      • Nancy, France
        • Department of Vascular Surgery, University Hospital of Nancy
      • Nantes, France
        • CHU Nantes, l'institut du thorax, service de chirurgie cardio-vasculaire
      • Nice, France
        • University Hospital of Nice, Université Côte d'Azur
      • Paris, France
        • Department of Vascular and Thoracic Surgery, Bichat Hospital, Paris, Université de Paris
      • Paris, France
        • Department of Vascular Surgery, Ambroise Paré University Hospital, Boulogne-Billancourt and Simone Veil Health Sciences Medical School, Versailles-Saint-Quentin-en-Yvelines University and Paris-Saclay University
      • Paris, France
        • Vascular Surgery Department, Georges Pompidou European Hospital, APHP, Paris University
      • Reims, France
        • Department of Vascular Surgery, CHU de Reims
      • Strasbourg, France
        • Department of Vascular Surgery and Kidney Transplantation, University Hospitals of Strasbourg
  • Germany
      • Aachen, Germany
        • European Vascular Center Aachen-Maastricht, University Hospital Aachen, RWTH Aachen University
      • Cologne, Germany
        • University Hospital Cologne
      • Dresden, Germany
        • Division of Vascular and Endovascular Surgery Department for Visceral-, Thoracic and Vascular Surgery Medical Faculty Carl Gustav Carus and University Hospital Carl Gustav Carus Dresden Technische Universität Dresden
      • Düsseldorf, Germany
        • Department of Vascular- and Endovascular Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf
      • Münster, Germany
        • Department of Vascular and Endovascular Surgery, University Hospital Münster
  • Hungary
      • Budapest, Hungary
        • Department of Vascular and Endovascular Surgery, Heart and Vascular Center, Semmelweis University
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of
        • University Hopspital Chișinău
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Amsterdam University Medical Center, Department of Surgery
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht, Department of Vascular Surgery
  • Serbia
      • Belgrade, Serbia
        • Clinic for Vascular and Endovascular Surgery, Clinical Center of Serbia
      • Belgrade, Serbia
        • Institute for Cardiovascular Disease, Belgrade
      • Niš, Serbia
        • Clinic for Vascular Surgery, Clinical Center Niš
  • Switzerland
      • Bern, Switzerland, 3010
        • Department of Cardiovascular Surgery, Inselspital, University of Bern
      • Winterthur, Switzerland
        • Department of Vascular Surgery, Kantonsspital Winterthur
  • United Kingdom
      • Bristol, United Kingdom
        • Bristol Centre for Surgical Research, Bristol NIHR Biomedical Research Centre, University of Bristol
      • Cardiff, United Kingdom
        • Department of Vascular Surgery, University Hospital Wales
      • Edinburgh, United Kingdom, EH1 3EG
        • NHS Lothian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with the diagnosis of acute lower limb ischemia treated at a participating study center.

Description

Inclusion Criteria:

  • Acute lower limb ischemia (Rutherford Categories I-III)

Exclusion Criteria:

  • No informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute lower limb ischemia
Patients with acute lower limb ischemia (older than 18 years)
Procedure: Revascularization
Endovascular or surgical restoration of arterial blood flow.
Other Names:
  • Surgical embolectomy
  • Peripheral bypass
  • Catheter directed thrombolysis
  • Catheter guided aspiration
  • Catheter guided atherectomy
  • Percutaneous transluminal angioplasty
Procedure: Primary major amputation
Primary below- or above knee major amputation without prior revascularization.
Other: Best medical treatment
Conservative treatment of acute lower limb ischemia - without prior revascularization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amputation free survival - rate
Time Frame: 90 days
Rate of amputation free survival after diagnosis of acute lower limb ischemia
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Re-intervention rate of the index leg
Time Frame: 90 days
Rate of re-intervention for revascularization or complications of the index-leg
90 days
Complication rate
Time Frame: 90 days
Rate of complications after the diagnosis of acute limb ischemia (access site infection, acute kidney injury, periprocedural major bleeding, compartment syndrome, multi organ failure)
90 days
Limb salvage rate
Time Frame: 90 days
Rate of patients not requiring major amputation.
90 days
Survival rate
Time Frame: 90 days
Rate of patients surviving the diagnosis of acute limb ischemia until the end of follow-up
90 days
Clinical outcome of the index leg (Rutherford category)
Time Frame: 90 days
Clinical symptoms at the end of follow up (Rutherford category)
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Investigators

  • Principal Investigator: Florian K Enzmann, MD, PhD, Department of Vascular Surgery, Medical University of Innsbruck
  • Principal Investigator: Alexandra Gratl, MD, Department of Vascular Surgery, Medical University of Innsbruck

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

November 15, 2021

First Submitted That Met QC Criteria

November 30, 2021

First Posted (Actual)

December 1, 2021

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1220/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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