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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05963620
Enrollment
201
Registered
2023-07-27
Start date
2023-01-01
Completion date
2024-02-29
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Coronary Stenosis

Keywords

Percutaneous coronary intervention, sirolimus-eluting stent, coronary artery bypass grafting

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.

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.

Interventions

OTHERpercutaneous coronary intervention vs bypass graft surgery

retrieve long term follow up data on clinical outcome of study population, no intervention

Sponsors

Heart Center Leipzig - University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
All-cause deathapproximately 15 years after procedurefurther categorized into cardiovascular, noncardiovascular, and undetermined deaths

Secondary

MeasureTime frameDescription
composite secondary endpointapproximately 15 years after procedureall-cause death, myocardial infarction or repeat target vessel revascularization

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026