Coronary Artery DiseaseNCT00299429
MIDCAB Versus DES in Proximal LAD Lesions
A study testing Stenting and minimally invasive bypass surgery and PCI with DES in people with Coronary Artery Disease, run by University of Leipzig at 1 site in Germany.
Trial summary
Percutaneous coronary intervention with a sirolimus-coated stent compared to minimally invasive bypass surgery in patients with isolated proximal left anterior descending coronary arteries in terms of non-inferiority of an end point combining mortality, acute myocardial infarction and rate of reintervention of the… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Stenting and minimally invasive bypass surgery and PCI with DES
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2003to Jul 2008
- Phase
- Interventional
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single-vessel disease of the proximal LAD with a stenosis > 50% (multivessel disease only if further coronary vessel stenoses do not require treatment)
- Patients with angina pectoris (CCS 1-4)
- Asymptomatic patients if clear signs of ischemia in the segments supplied by the LAD as assessed by bicycle ergometry or treadmill and/or scintigraphically and/or stress echo
- Patients for whom both methods of treatment are equally possible
- Consensus between the cardiac surgeon and the cardiologist that both inclusion and exclusion criteria are met in the selected case
- Informed consent of the patient.
Who cannot join
- Patients < 18 years
- Pregnancy
- Previous coronary artery bypass surgery
- Concomitant diseases that lead to a greater risk for each of the treatment strategies
- Significant peripheral arterial occlusive disease
- Concomitant disease with limited life expectancy (e.g. malignant tumours that have not been curatively treated)
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- Objective follow-up examination not possible due to physical or mental handicap
- Participation in another study.
- Angiographical exclusion criteria:
- Left main stem stenosis
- Multivessel disease for which surgical or interventional therapy on other vessel areas is required.
- Diagonal/septal branch > 1.5 mm, which might be compromised by a stent
- Need for acute intervention (e.g. acute myocardial infarction)
- Total occlusion of the LAD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Comparison of Minimally Invasive Direct Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention With Drug-eluting Stents in Patients With Proximal Stenosis of the Left Anterior Descending Coronary Artery
Percutaneous coronary intervention with a sirolimus-coated stent compared to minimally invasive bypass surgery in patients with isolated proximal left anterior descending coronary arteries in terms of non-inferiority of an end point combining mortality, acute myocardial infarction and rate of reintervention of the target vessel within one year.
- Conditions
- Coronary Artery Disease
- Being tested
- Stenting and minimally invasive bypass surgery, PCI with DES
- Keywords
- Stent, drug-eluting stent, Minimally invasive bypass surgery, left anterior descending
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stenting and minimally invasive bypass surgeryProcedure or surgery
PCI with DESProcedure or surgery
PCI with DES
| Study group | Role | What they receive |
|---|---|---|
| MIDCAB Surgery | Active comparator | MIDCAB Surgery Receives: Procedure: Stenting and minimally invasive bypass surgery |
| PCI with drug-eluting stent | Experimental | PCI with DES Receives: Procedure: PCI with DES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
Measured: 12 months
Secondary outcomes (3)
Perioperative complications
Measured: 30 days
CCS-Classification
Measured: 12 months
cost-effectiveness
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2006 (estimated)
- Study startJan 2003
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Cordis Medizinische Apparate GmbH
- Responsible party
- Sponsor
- Investigators
- Holger Thiele, MD, Principal investigator, Heart Center Leipzig - University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299429
- Sponsor's protocol ID
- 2-Thiele
- Status last verified
- Mar 2007
- First submitted
- 9 Sep 2005
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Blazek S, Rossbach C, Borger MA, Fuernau G, Desch S, Eitel I, Stiermaier T, Lurz P, Holzhey D, Schuler G, Mohr FW, Thiele H. Comparison of sirolimus-eluting stenting with minimally invasive bypass surgery for stenosis of the left anterior descending coronary artery: 7-year follow-up of a randomized trial. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):30-8. doi: 10.1016/j.jcin.2014.08.006. Epub 2014 Dec 10.
PubMed 25499302Thiele H, Neumann-Schniedewind P, Jacobs S, Boudriot E, Walther T, Mohr FW, Schuler G, Falk V. Randomized comparison of minimally invasive direct coronary artery bypass surgery versus sirolimus-eluting stenting in isolated proximal left anterior descending coronary artery stenosis. J Am Coll Cardiol. 2009 Jun 23;53(25):2324-31. doi: 10.1016/j.jacc.2009.03.032.
PubMed 19539141
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Comparison of Minimally Invasive Direct Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention With Drug-eluting Stents in Patients With Proximal Stenosis of the Left Anterior Descending Coronary Artery
- ClinicalTrials.gov ID
- NCT00299429
- Acronym / sponsor ID
- 2-Thiele
- Conditions
- Coronary Artery Disease
- Keywords
- Stent, drug-eluting stent, Minimally invasive bypass surgery, left anterior descending
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Cordis Medizinische Apparate GmbH
- Study start
- Jan 2003
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 6 Mar 2006 (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.
Percutaneous coronary intervention with a sirolimus-coated stent compared to minimally invasive bypass surgery in patients with isolated proximal left anterior descending coronary arteries in terms of non-inferiority of an end point combining mortality, acute myocardial infarction and rate of reintervention of the target vessel within one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIDCAB Surgery | Active comparator | Procedure: Stenting and minimally invasive bypass surgeryMIDCAB Surgery |
| PCI with drug-eluting stent | Experimental | Procedure: PCI with DESPCI with DES |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Single-vessel disease of the proximal LAD with a stenosis > 50% (multivessel disease only if further coronary vessel stenoses do not require treatment)
- Patients with angina pectoris (CCS 1-4)
- Asymptomatic patients if clear signs of ischemia in the segments supplied by the LAD as assessed by bicycle ergometry or treadmill and/or scintigraphically and/or stress echo
- Patients for whom both methods of treatment are equally possible
- Consensus between the cardiac surgeon and the cardiologist that both inclusion and exclusion criteria are met in the selected case
Key exclusion criteria (14 listed)
- Patients < 18 years
- Pregnancy
- Previous coronary artery bypass surgery
- Concomitant diseases that lead to a greater risk for each of the treatment strategies
- Significant peripheral arterial occlusive disease
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 |
|---|---|---|
| Stenting and minimally invasive bypass surgery | Procedure or surgery | MIDCAB Surgery |
| PCI with DESPCI with DES | Procedure or surgery | PCI with drug-eluting stent |
Primary outcome
Major adverse cardiac events
Time frame: 12 months
3 secondary outcomes
Perioperative complications
Time frame: 30 days
CCS-Classification
Time frame: 12 months
cost-effectiveness
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Derived from this study: PubMed 25499302Blazek S, Rossbach C, Borger MA, Fuernau G, Desch S, Eitel I, Stiermaier T, Lurz P, Holzhey D, Schuler G, Mohr FW, Thiele H. Comparison of sirolimus-eluting stenting with minimally invasive bypass surgery for stenosis of the left anterior descending coronary artery: 7-year follow-up of a randomized trial. JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):30-8. doi: 10.1016/j.jcin.2014.08.006. Epub 2014 Dec 10.
- Derived from this study: PubMed 19539141Thiele H, Neumann-Schniedewind P, Jacobs S, Boudriot E, Walther T, Mohr FW, Schuler G, Falk V. Randomized comparison of minimally invasive direct coronary artery bypass surgery versus sirolimus-eluting stenting in isolated proximal left anterior descending coronary artery stenosis. J Am Coll Cardiol. 2009 Jun 23;53(25):2324-31. doi: 10.1016/j.jacc.2009.03.032.
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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.
Holger Thiele, MD principal investigator
Heart Center Leipzig - University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stenting and minimally invasive bypass surgery and PCI with DES in people with Coronary Artery Disease, run by University of Leipzig at 1 site in Germany.
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 6 inclusion and 14 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: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00299429, which also lists 2 linked publications.
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 26 Jun 2018; AzTrials last refreshed its copy on 4 Nov 2026.