PROMOTE-ALI: Evaluation of Acute Lower Limb Ischemia

Sponsor

Medical University Innsbruck (Other)

Overall Status

Recruiting

CT.gov ID

NCT05138679

Collaborator

(none)

500

Enrollment

Locations

Anticipated Duration (Months)

9.6

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Limb Ischemia	Procedure: Revascularization Procedure: Primary major amputation Other: Best medical 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guidelines highlighted that the available evidence on the management of acute lower limb ischemia (ALI) is mostly outdated and includes only small patient cohorts.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 Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Multicenter Observational Study Evaluating Acute Lower Limb Ischemia

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Amputation free survival - rate [90 days]
Rate of amputation free survival after diagnosis of acute lower limb ischemia

Secondary Outcome Measures

Re-intervention rate of the index leg [90 days]
Rate of re-intervention for revascularization or complications of the index-leg
Complication rate [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)
Limb salvage rate [90 days]
Rate of patients not requiring major amputation.
Survival rate [90 days]
Rate of patients surviving the diagnosis of acute limb ischemia until the end of follow-up
Clinical outcome of the index leg (Rutherford category) [90 days]
Clinical symptoms at the end of follow up (Rutherford category)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Acute lower limb ischemia (Rutherford Categories I-III)

Exclusion Criteria:

No informed consent

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Department of Vascular Surgery, LKH Feldkirch	Feldkirch	Austria
2	Department of Vascular Surgery, Medical University Graz	Graz	Austria	8036
3	Medical University of Innsbruck, Department of Vascular Surgery	Innsbruck	Austria	6020
4	Department of General Surgery, Division of Vascular Surgery, Medical University of Vienna	Vienna	Austria	1090
5	Department of Vascular and Endovascular Surgery, Hospital Ottakring	Vienna	Austria	1160
6	Department of Cardio-Vascular Surgery, Clinic Floridsdorf and Karl Landsteiner Institute for Cardio-Vascular Research	Vienna	Austria	1210
7	Department of Vascular Surgery, Kolding	Kolding	Denmark
8	Department of Vascular Surgery, Hospital of Antibes Juan-les-Pins	Antibes	France
9	Department of Vascular and Endovascular Surgery, University Hospital of Besançon	Besançon	France
10	Department of Vascular Surgery, Bordeaux University Hospital	Bordeaux	France
11	Department of Vascular and Endovascular Surgery, Brest University Hospital	Brest	France
12	Department of Vascular Surgery, Henri Mondor University Hospital	Créteil	France
13	Department of Vascular Surgery, University Hospital of Dijon	Dijon	France
14	Vascular Surgery Department, Hospices Civils de Lyon	Lyon	France
15	Department of Vascular Surgery, University Hospital of Nancy	Nancy	France
16	CHU Nantes, l'institut du thorax, service de chirurgie cardio-vasculaire	Nantes	France
17	Department of Vascular Surgery, University Hospital of Nice	Nice	France
18	University Hospital of Nice, Université Côte d'Azur	Nice	France
19	Department of Vascular and Thoracic Surgery, Bichat Hospital, Paris, Université de Paris	Paris	France
20	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
21	Vascular Surgery Department, Georges Pompidou European Hospital, APHP, Paris University	Paris	France
22	Department of Vascular Surgery, CHU de Reims	Reims	France
23	Department of Vascular Surgery and Kidney Transplantation, University Hospitals of Strasbourg	Strasbourg	France
24	European Vascular Center Aachen-Maastricht, University Hospital Aachen, RWTH Aachen University	Aachen	Germany
25	Clinic for Vascular and Endovascular Surgery, Medical Faculty, University Augsburg	Augsburg	Germany
26	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	Dresden	Germany
27	Department of Vascular- and Endovascular Surgery, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf	Düsseldorf	Germany
28	Department of Surgery, Medical Faculty Mannheim	Mannheim	Germany
29	Department of Vascular Surgery, Ludwig-Maximilians University Hospital	Munich	Germany
30	Department of Vascular and Endovascular Surgery, University Hospital Münster	Münster	Germany
31	Department of Experimental, Diagnostic and Specialty Medicine (DIMES), University of Bologna	Bologna	Italy
32	Amsterdam University Medical Center, Department of Surgery	Amsterdam	Netherlands	1105 AZ
33	Dijklander hospital, Department of Surgery	Hoorn	Netherlands	1624 NP
34	University Medical Center Utrecht, Department of Vascular Surgery	Utrecht	Netherlands	3584 CX
35	Department of Vascular and Endovascular Surgery, Haukeland University Hospital	Bergen	Norway
36	Vascular Surgery Department, Algarve University Medical Centre	Faro	Portugal
37	Department of Vascular and Endovascular Surgery, Santa Marta Hospital, Centro Hospitalar Lisboa Central	Lisbon	Portugal
38	Department of Angiology and Vascular Surgery, Hospital de S. João	Porto	Portugal
39	Clinic for Vascular and Endovascular Surgery, Clinical Center of Serbia	Belgrade	Serbia
40	Institute for Cardiovascular Disease, Belgrade	Belgrade	Serbia
41	Clinic for Vascular Surgery, Clinical Center Niš	Niš	Serbia
42	Department of Angiology and Vascular Surgery, Hospital Vall D'Hebron	Barcelona	Spain
43	Department of Angiology and Vascular Surgery, Hospital Virgen de la Luz	Cuenca	Spain
44	Department of Angiology and Vascular Surgery, Hospital Universitario 12 de Octubre	Madrid	Spain
45	Department of Angiology and Vascular Surgery, Hospital General Universitario de Toledo	Toledo	Spain
46	Department of Angiology and Vascular Surgery, Hospital Clínico Universitario de Valladolid	Valladolid	Spain
47	Department of Angiology and Vascular Surgery, Hospital Miguel Servet	Zaragoza	Spain
48	Department of Cardiovascular Surgery, Inselspital, University of Bern	Bern	Switzerland	3010
49	Department of Vascular Surgery, Kantonsspital Winterthur	Winterthur	Switzerland
50	Bristol Centre for Surgical Research, Bristol NIHR Biomedical Research Centre, University of Bristol	Bristol	United Kingdom
51	Department of Vascular Surgery, University Hospital Wales	Cardiff	United Kingdom
52	Department of Vascular Surgery, Countess of Chester Hospital	Chester	United Kingdom

Sponsors and Collaborators

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