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NCT05963620 Clinical Trial

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

Coronary Artery Disease Clinical Trial

Official title:
Long-term Follow-up of a Randomized Comparison of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Surgery in Unprotected Left Main Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05963620
Other study ID # 2021-0444
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date February 2024

Study information
Verified date July 2023
Source Heart Center Leipzig - University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 201
Est. completion date February 2024
Est. primary completion date February 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• percutaneous coronary intervention vs bypass graft surgery
retrieve long term follow up data on clinical outcome of study population, no intervention

Locations
Country Name City State
Germany Universitäts-Herzzentrum Freiburg Bad Krozingen Bad Krozingen Baden Würtemberg
Germany Heart Center Leipzig at University of Leipzig Leipzig Saxony
Germany Klinikum der Ludwig-Maximilians Universität München München Bayern
Germany München Klinik Neuperlach München Bayern

Sponsors (1)
Lead Sponsor Collaborator
Heart Center Leipzig - University Hospital

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary All-cause death further categorized into cardiovascular, noncardiovascular, and undetermined deaths approximately 15 years after procedure
Secondary composite secondary endpoint all-cause death, myocardial infarction or repeat target vessel revascularization approximately 15 years after procedure
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