Intermittent ClaudicationABCNCT01177033
Angioplasty or Bypass Surgery in Intermittent Claudication
An observational study of Intermittent Claudication and Complex Lesions of the Superficial Femoral Artery, run by Institut für Klinisch-Kardiovaskuläre Forschung GmbH at 25 sites in 2 countries.
Trial 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 lesions of the superficial femoral artery CONDITION Peripheral arterial occlusive disease (PAOD) OBJECTIVE(S) The objective… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Intermittent Claudication, Complex Lesions of the Superficial Femoral Artery
- What is being tested?
- Best endovascular treatment or Best surgical treatment
- How many people
- 470 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Aug 2010to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Intermittent Claudication, due to complex lesions of the superficial femoral artery
Who may be able to join
- 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.
Show all 9Show fewer
- 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).
Who cannot join
- >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
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
Germany23 sites, 23 recruiting
- Not yet recruiting
Universitätsklinikum Aachen
Aachen, 52074
M. Jacobs, Prof. Dr., +49-241-8080832, mjacobs@ukaachen.de
- Not yet recruiting
Klinikum Augsburg
Augsburg, 86156
Klaus Wölfle, Prof. Dr., +49-821-4002655, klaus.woelfle@klinikum-augsburg.de
- Not yet recruiting
Klinikum am Bruderwald
Bamberg, 96049
Heinz Weber, Dr., +49951-50312151, heinz.weber@sozialstiftung-bamberg.de
- Not yet recruiting
Bundeswehrkrankenhaus Berlin
Berlin, 10115
Malte Hegenscheid, Dr., +493028411291, maltehegenscheid@bundeswehr.org
- Not yet recruiting
Uniklinik Bonn
Bonn, 53127
Frauke Verrel, Dr., +49 22828715109, frauke.verrel@ukb.uni-bonn.de
- Not yet recruiting
Klinikum und Fachbereich Medizin Johann Wolfgang Goethe Universität Frankfurt am Main
Frankfurt am Main, 60590
Schmitz-Rixen, Prof. Dr., +49 6963015349, schmitz-rixen@em.uni-frankfurt.de
- Not yet recruiting
Universitätsherzzentrum / Klinik und Poliklinik für Gefäßmedizin
Hamburg, 20246
S. Debus, Prof. Dr., +4940-741053876, debus@uke.de
- Not yet recruiting
Klinikum Hanau
Hanau, 63450
Hardy Schumacher, Prof. Dr., +49-6181-2962310, hardy_schumacher@klinikum-hanau.de
- Not yet recruiting
Universitätsklinikum Heidelberg
Heidelberg, 69120
Dittmar Böckler, Prof. Dr., +49 6221 - 566110, dittmar.boeckler@med.uni-heidelberg.de
- Not yet recruiting
Klinikum Ingolstadt
Ingolstadt, 85049
Volker Ruppert, PD Dr, +49 841-8802425, volker.ruppert@klinikum-ingolstadt.de
- Not yet recruiting
Städtisches Klinikum Karlsruhe
Karlsruhe, 76133
Martin Storck, Prof. Dr., +49721-9742301, martin.storck@klinikum-karlsruhe.de
- Not yet recruiting
Klinikum Ludwigsburg
Ludwigsburg, 71640
Johannes Gahlen, Prof.Dr, +49 7141-9966401, johannes.gahlen@kliniken-lb.de
- Not yet recruiting
Klinikum der Johannes Gutenberg Unviersität Mainz
Mainz, 55131
Christoph Düber, Prof.Dr, +49 6131-173208, dueber@radiologie.klinik.uni-mainz.de
- Not yet recruiting
Universitätsklinikum Mannheim
Mannheim, 68167
M. Niedergethmann, Prof. Dr.
- Not yet recruiting
Evangelisches Krankenhaus Mühlheim
Mühlheim, 45468
Alexander Stehr, PD Dr., +49 - 208 - 3092440, Alexander.Stehr@evkmh.de
- Not yet recruiting
Klinikum der Universität München, Chirurgische Klinik und Poliklinik Innenstadt
München, 80336
Ulrich Hoffmann, Prof. Dr., +49 89 51603601, Ulrich.Hoffmann@med.uni-muenchen.de
- Recruiting
Klinikum Rechts der Isar, Technische Universität München
München, 81675
Hans-Henning Eckstein, Prof. Dr., +49-89-41402167, H.H.Eckstein@lrz.tum.de
- Not yet recruiting
Universitätsklinikum Münster
Münster, 48149
Giovanni Torsello, Prof. Dr., +49251-8345782, Giovanni.Torsello@ukmuenster.de
- Not yet recruiting
Universitätsklinikum Regensburg
Regensburg, 93053
Piotr Kasprzak, PD Dr., +49 941-9446911, piotr.kasprzak@klinik.uni-regensburg.de
- Not yet recruiting
Diakonissen-Stiftungs-Krankenhaus Speyer
Speyer, 67346
Gerhard Rümenapf, Prof. Dr., +49 - 6232-221955, gerhard.ruemenapf@diakonissen-speyer.de
- Not yet recruiting
Katharinenhospital Stuttgart
Stuttgart, 70174
Thomas Hupp, Prof.Dr., +49711-27833601, t.hupp@klinikum-stuttgart.de
- Not yet recruiting
Universtitätsklinikum Ulm
Ulm, 89075
Karl-Heinz Orend, Prof. Dr., +49-731-500544001, karl-heinz.orend@uniklinik-ulm.de
- Not yet recruiting
HSK Dr. Horst Schmidt Klinik
Wiesbaden, 65199
Achim Neufang, PD Dr., achim.neufang@hsk-wiesbaden.de
Austria2 sites, 2 recruiting
- Not yet recruiting
Medizinische Universität Innsbruck
Innsbruck, 6020
Gustav Fraedrich, Prof. Dr., +43 050 50422587, Gustav.Fraedrich@i-med.ac.at
- Not yet recruiting
Wilhelminenhospital Wien
Vienna, 1160
Afshin Assadian, PD Dr, +43149150-4101, wil1chsek@wienkav.at
About this study
Official title: ABC-Trial - Angioplasty or Bypass Surgery in Intermittent Claudication:
CLINICAL TRIAL PROTOCOL SUMMARY / SYNOPSIS
Phase: IV
Read more
TITLE OF STUDY
Angioplasty or Bypass Surgery in Intermittent Claudication (ABC-Trial): a randomised controlled trial for patients with complex lesions of the superficial femoral artery
CONDITION
Peripheral arterial occlusive disease (PAOD)
OBJECTIVE(S)
The objective of this study is to evaluate the safety and efficacy of two therapeutic strategies (operative versus endovascular) in the treatment of patients with complex atherosclerotic lesions of the superficial femoral artery.
INTERVENTIONS
Intervention type I: Best endovascular treatment (stent-protected angioplasty). Intervention type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous vein (1° choice) or a prosthetic graft (if vein is not available).
Duration of intervention per patient: Dependent on the method of treatment
Follow-up per patient: 24 months
OUTCOMES
Primary efficacy endpoint:
Two primary efficacy endpoints will be considered simultaneously in this trial:
(A) Event-free survival (time-to-event endpoint): Proportion (over the course of time) of surviving patients who show a continuing clinical improvement of >= 1 class (Rutherford classification) without the need for repeated target lesion revascularization (TLR).
(B) Proportion of surviving patients with clinical improvement of >= 1 class (Rutherford classification) at 24 months after primary intervention (regardless any performed re-intervention).
- Being tested
- Best endovascular treatment or Best surgical treatment
- Medical subject headings
- Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best endovascular treatment or Best surgical treatmentOther
Intervention type I: Best endovascular treatment (stent-protected angioplasty). Intervention type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous vein (1° choice) or a prosthetic graft (if vein is not available).
| Study group | Role | What they receive |
|---|---|---|
| Best endovascular treatment | Intervention type I: Best endovascular treatment (stent-protected angioplasty). Intervention type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous vein (1° choice) or a prosthetic graft (if vein is not available). Receives: Other: Best endovascular treatment or Best surgical treatment | |
| Best surgical treatment | Intervention type I: Best endovascular treatment (stent-protected angioplasty). Intervention type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous vein (1° choice) or a prosthetic graft (if vein is not available). Receives: Other: Best endovascular treatment or Best surgical treatment |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2012 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut für Klinisch-Kardiovaskuläre Forschung GmbH
- Sponsor type
- Research network
- Collaborators
- Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177033
- Sponsor's protocol ID
- ISRCTN 39997806
- Other IDs
- 2010-021374-10
- Acronym
- ABC
- Status last verified
- May 2010
- First submitted
- 5 Aug 2010
- Last updated
- 6 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABC-Trial - Angioplasty or Bypass Surgery in Intermittent Claudication:
- ClinicalTrials.gov ID
- NCT01177033
- Acronym / sponsor ID
- ABC / ISRCTN 39997806
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Institut für Klinisch-Kardiovaskuläre Forschung GmbHResearch network
- Collaborators
- Technical University of Munich
- Study start
- Aug 2010
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 6 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 lesions of the superficial femoral artery
CONDITION
Peripheral arterial occlusive disease (PAOD)
OBJECTIVE(S)
The objective of this study is to evaluate the safety and efficacy of two therapeutic strategies (operative versus endovascular) in the treatment of patients with complex atherosclerotic lesions of the superficial femoral artery.
INTERVENTIONS
Intervention type I: Best endovascular treatment (stent-protected angioplasty). Intervention type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous vein (1° choice) or a prosthetic graft (if vein is not available).
Duration of intervention per patient: Dependent on the method of treatment
Follow-up per patient: 24 months
OUTCOMES
Primary efficacy endpoint:
Two primary efficacy endpoints will be considered simultaneously in this trial:
(A) Event-free survival (time-to-event endpoint): Proportion (over the course of time) of surviving patients who show a continuing clinical improvement of >= 1 class (Rutherford classification) without the need for repeated target lesion revascularization (TLR).
(B) Proportion of surviving patients with clinical improvement of >= 1 class (Rutherford classification) at 24 months after primary intervention (regardless any performed re-intervention).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best endovascular treatment | – | Other: Best endovascular treatment or Best surgical treatmentIntervention type I: Best endovascular treatment (stent-protected angioplasty). Intervention type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous vein (1° choice) or a prosthetic graft (if vein is not available). |
| Best surgical treatment | – | Other: Best endovascular treatment or Best surgical treatmentIntervention type I: Best endovascular treatment (stent-protected angioplasty). Intervention type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous vein (1° choice) or a prosthetic graft (if vein is not available). |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Intermittent Claudication, due to complex lesions of the superficial femoral artery
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- >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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best endovascular treatment or Best surgical treatmentIntervention type I: Best endovascular treatment (stent-protected angioplasty). Intervention type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous vein (1° choice) or a prosthetic graft (if vein is not available). | Other | Best endovascular treatment, Best surgical treatment |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2010.
Related trials for Intermittent Claudication
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Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intermittent Claudication and Complex Lesions of the Superficial Femoral Artery, run by Institut für Klinisch-Kardiovaskuläre Forschung GmbH at 25 sites in 2 countries.
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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Germany, Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 6 Aug 2010.