Status:
UNKNOWN
Angioplasty or Bypass Surgery in Intermittent Claudication
Lead Sponsor:
Institut für Klinisch-Kardiovaskuläre Forschung GmbH
Collaborating Sponsors:
Technical University of Munich
Conditions:
Intermittent Claudication
Complex Lesions of the Superficial Femoral Artery
Eligibility:
All Genders
50-85 years
Brief Summary
CLINICAL TRIAL PROTOCOL SUMMARY / SYNOPSIS Phase: IV TITLE OF STUDY Angioplasty or Bypass Surgery in Intermittent Claudication (ABC-Trial): a randomised controlled trial for patients with complex l...
Eligibility Criteria
Inclusion
- Patient is able to verbally acknowledge and understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial. The patients, by providing informed consent, agree to these risks and benefits as stated in the patient informed consent document.
- Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol.
- Age ≥ 50 and ≤ 85 years old.
- Intermittent claudication (IC) class 2 or 3 (Rutherford) assessed by treadmill testing or 6-Minute Walk Test.
- Lasting \>3 months.
- Failed conservative therapy and the patient's desire for further treatment.
- Atherosclerotic single or multiple stenoses (\>50%) or an occlusion of the Superficial Femoral Artery (SFA) with a target lesion length of 10-20 cm without involvement of the common/deep femoral artery and/or the popliteal artery confirmed by duplex ultrasound and angiography.
- At least one patent tibioperoneal artery with no stenosis \>50% in diameter. Technical and morphological accessibility for both catheter intervention and bypass surgery.
- Absence of other disease that would limit exercise (e.g. angina or chronic respiratory disease).
Exclusion
- \>50% stenosis or occlusion of the iliac, the common, the deep femoral or the popliteal artery.
- Surgical reconstruction or catheter intervention on the index leg within the last six months.
- Unsuitability of treadmill testing / Six-Minute Walk Test. Chronic limb ischemia (intermittent claudication class 2 to 6) on the contralateral leg.
- Known allergy to contrast agents containing iodine.
- Contraindication for antiplatelet agents or anticoagulants.
- Clinically manifested heart insufficiency (NYHA III, IV) and/or uncorrected hyperthyreosis.
- Serious general disease state with an estimated life expectancy \< 2 years (ASA IV, V).
- Pregnancy
Key Trial Info
Start Date :
August 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
470 Patients enrolled
Trial Details
Trial ID
NCT01177033
Start Date
August 1 2010
End Date
December 1 2014
Last Update
August 6 2010
Active Locations (25)
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1
Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
2
Wilhelminenhospital Wien
Vienna, Austria, 1160
3
Universitätsklinikum Aachen
Aachen, Germany, 52074
4
Klinikum Augsburg
Augsburg, Germany, 86156