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Long-term Follow-up of a Randomized Comparison of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Surgery

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ClinicalTrials.gov Identifier: NCT05963620
Recruitment Status : Enrolling by invitation
First Posted : July 27, 2023
Last Update Posted : July 27, 2023
Sponsor:
Information provided by (Responsible Party):
Heart Center Leipzig - University Hospital

Study Description
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Brief Summary:

This is a long-term follow-up of a completed clinical trial which compared percutaneous coronary intervention (PCI) using sirolimus-eluting stents and coronary artery bypass grafting (CABG) in patients with unprotected left main coronary artery disease.

The purpose of the study is to obtain retrospective long-term data on clinical outcome of the study population.


Condition or disease Intervention/treatment
Coronary Stenosis Coronary Artery Disease Other: percutaneous coronary intervention vs bypass graft surgery

Detailed Description:

The randomized multicenter, open-label trial "Percutaneous Coronary Intervention (PCI) With Drug-Eluting Stents (DES) Versus Coronary Artery Bypass Graft (CABG) for Patients With Significant Left Main Stenosis" was conducted at 4 tertiary care centers in Germany. 201 patients with unprotected left main stem stenosis (≥50%) with or without additional multivessel coronary artery disease were enrolled in a 1:1 ratio from July 2003 through February 2009. Results were published: https://pubmed.ncbi.nlm.nih.gov/21272743/

Long-term follow-up will be performed by a structured telephone interview using a standardized questionnaire by an interviewer blinded to treatment allocation. Wherever possible, data will be completed and verified by health care records. Retrospective data of the underlying randomized study will be included in data analysis.

Study Design
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Study Type : Observational
Estimated Enrollment : 201 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Follow-up of a Randomized Comparison of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Surgery in Unprotected Left Main Disease
Actual Study Start Date : January 1, 2023
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
percutaneous coronary intervention (PCI)
percutaneous coronary intervention (PCI) with sirolimus-eluting stents
 Other: percutaneous coronary intervention vs bypass graft surgery
retrieve long term follow up data on clinical outcome of study population, no intervention
coronary artery bypass grafting (CABG)
coronary artery bypass graft surgery
 Other: percutaneous coronary intervention vs bypass graft surgery
retrieve long term follow up data on clinical outcome of study population, no intervention


Outcome Measures
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Primary Outcome Measures :
  1. All-cause death [ Time Frame: approximately 15 years after procedure ]
    further categorized into cardiovascular, noncardiovascular, and undetermined deaths


Secondary Outcome Measures :
  1. composite secondary endpoint [ Time Frame: approximately 15 years after procedure ]
    all-cause death, myocardial infarction or repeat target vessel revascularization


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
participants of the preceding study: Percutaneous Coronary Intervention (PCI) With Drug-Eluting Stents (DES) Versus Coronary Artery Bypass Graft (CABG) for Patients With Significant Left Main Stenosis
Criteria

Inclusion Criteria:

  • alive participants of underlying study who give their consent to participate
  • deceased participants of underlying study

Exclusion Criteria:

  • alive participants of underlying study who do not consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05963620


Locations
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Germany
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, Baden Würtemberg, Germany, 79189
Klinikum der Ludwig-Maximilians Universität München
München, Bayern, Germany, 80336
München Klinik Neuperlach
München, Bayern, Germany, 81737
Heart Center Leipzig at University of Leipzig
Leipzig, Saxony, Germany, 04289
Sponsors and Collaborators
Heart Center Leipzig - University Hospital
Investigators
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Study Chair: Steffen Desch, MD Heart Center Leipzig at University of Leipzig
More Information
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Responsible Party: Heart Center Leipzig - University Hospital
ClinicalTrials.gov Identifier: NCT05963620    
Other Study ID Numbers: 2021-0444
First Posted: July 27, 2023    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heart Center Leipzig - University Hospital:
Percutaneous coronary intervention
sirolimus-eluting stent
coronary artery bypass grafting
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases