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

NCT ID: NCT05963620

Last Updated: 2023-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Stenosis Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

percutaneous coronary intervention (PCI)

percutaneous coronary intervention (PCI) with sirolimus-eluting stents

percutaneous coronary intervention vs bypass graft surgery

Intervention Type OTHER

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

coronary artery bypass grafting (CABG)

coronary artery bypass graft surgery

percutaneous coronary intervention vs bypass graft surgery

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

percutaneous coronary intervention vs bypass graft surgery

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Heart Center Leipzig - University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Steffen Desch, MD

Role: STUDY_CHAIR

Heart Center Leipzig at University of Leipzig

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitäts-Herzzentrum Freiburg Bad Krozingen

Bad Krozingen, Baden Würtemberg, Germany

Site Status

Klinikum der Ludwig-Maximilians Universität München

München, Bavaria, Germany

Site Status

München Klinik Neuperlach

München, Bavaria, Germany

Site Status

Heart Center Leipzig at University of Leipzig

Leipzig, Saxony, Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-0444

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Stent or Surgery (SoS) Trial
NCT00475449 COMPLETED NA