NCT00567801

Brief Summary

The purpose of this study is to prove the findings of a preliminary study which strongly suggest the hypothesis that the result of conventional embolectomy for acute, severe lower-limb ischemia can be improved by controlled reperfusion.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2002

Longer than P75 for phase_3

Geographic Reach
2 countries

23 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

July 28, 2008

Status Verified

July 1, 2008

Enrollment Period

7 years

First QC Date

December 4, 2007

Last Update Submit

July 25, 2008

Conditions

Lower Extremity Ischemia

Keywords

Lower ExtremityIschemia

Outcome Measures

Primary Outcomes (1)

  • Amputation-free survival

    28 days

Secondary Outcomes (4)

  • Neurological status (motor function, sensor function) of ischemic limb

    4 weeks

  • Systemic complications in both therapy groups

    4 weeks

  • Tolerance of reperfusion solution

    4 weeks

  • Lethality

    12 months

Study Arms (2)

1

ACTIVE COMPARATOR

conventional embolectomy/thrombectomy

Procedure: conventional embolectomy/thrombectomy

2

EXPERIMENTAL

embolectomy/thrombectomy with controlled reperfusion

Procedure: embolectomy/thrombectomy with controlled reperfusion

Interventions

conventional embolectomy/thrombectomyPROCEDURE
1
embolectomy/thrombectomy with controlled reperfusionPROCEDURE
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 years or older
  • Patients with arterial occlusion of one or both lower limbs with acute decompensated ischemia (Rutherford IIA to III)
  • Informed consent of the patient

You may not qualify if:

  • Previous attempt of recanalisation (e.g. lysis therapy)
  • Known A. poplitea aneurysm of the affected extremity
  • Severe heart failure NYHA IV
  • Known atrial thrombus
  • Terminal renal insufficiency (creatinine \>10mg/dl or current dialysis therapy, previous transplantation of kidney)
  • Hypersensitivity to allopurinol
  • Hypersensitivity to one component part of the reperfusion solution
  • Participation in a clinical trial during the study or 30 days before
  • Pregnancy or lactation
  • Patient incapable of contracting or not able to understand the character, meaning and consequences of the clinical trial
  • Abuse to drugs or alcohol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Universität Innsbruck

Innsbruck, Austria

Location

St. Johanns-Spital Salzburg

Salzburg, Austria

Location

University Medical Center Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Location

Städtisches Klinikum Karlsruhe

Karlsruhe, Baden-Wurttemberg, Germany

Location

Klinikum Lahr

Lahr, Baden-Wurttemberg, Germany

Location

Klinikum Villingen-Schwenningen

Villingen-Schwenningen, Baden-Wurttemberg, Germany

Location

Herzzentrum Bad Krozingen

Bad Krozingen, Germany

Location

Universitätsklinikum Bonn

Bonn, Germany

Location

Kreisklinikum Donaueschingen

Donaueschingen, Germany

Location

St. Johannes-Hospital Dortmund

Dortmund, Germany

Location

Marienhospital Altenessen

Essen, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, Germany

Location

St. Marien-Hospital Buer, Gelsenkirchen

Gelsenkirchen, Germany

Location

Universitätsklinikum Giessen

Giessen, Germany

Location

Herzzentrum Göttingen

Göttingen, Germany

Location

Uniklinik Hamburg-Eppendorf

Hamburg, Germany

Location

Universitätsklinikum Kiel

Kiel, Germany

Location

Park-Krankenhaus Leipzig

Leipzig, Germany

Location

Universitätsklinikum Lübeck

Lübeck, Germany

Location

Universitätsklinikum Mainz

Mainz, Germany

Location

Klinikum E. v. Bergmann Potsdam

Potsdam, Germany

Location

Universitätsklinikum Rostock

Rostock, Germany

Location

Hegau-Klinikum Singen

Singen, Germany

Location

Related Publications (1)

  • Wilhelm MP, Schlensak C, Hoh A, Knipping L, Mangold G, Dallmeier Rojas D, Beyersdorf F. Controlled reperfusion using a simplified perfusion system preserves function after acute and persistent limb ischemia: a preliminary study. J Vasc Surg. 2005 Oct;42(4):690-4. doi: 10.1016/j.jvs.2005.05.055.

    PMID: 16242556BACKGROUND

MeSH Terms

Conditions

Ischemia

Interventions

ThrombectomyEmbolectomy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Friedhelm Beyersdorf, Prof. Dr.

    Department of Cardiovascular Surgery, University Medical Center Freiburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 4, 2007

First Posted

December 5, 2007

Study Start

September 1, 2002

Primary Completion

September 1, 2009

Study Completion

September 1, 2010

Last Updated

July 28, 2008

Record last verified: 2008-07

Locations

AU(2)DE(21)