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

NCT05963620 | Unknown

• 1 other identifier: 2021-0444
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 4

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.

Conditions

Coronary Stenosis; Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• All-cause death

  further categorized into cardiovascular, noncardiovascular, and undetermined deaths

  approximately 15 years after procedure

Secondary Outcomes (1)

• composite secondary endpoint

  approximately 15 years after procedure

Study Arms (2)

percutaneous coronary intervention (PCI)

percutaneous coronary intervention (PCI) with sirolimus-eluting stents

Other: percutaneous coronary intervention vs bypass graft surgery

coronary artery bypass grafting (CABG)

coronary artery bypass graft surgery

Other: percutaneous coronary intervention vs bypass graft surgery

Interventions

percutaneous coronary intervention vs bypass graft surgery OTHER

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

coronary artery bypass grafting (CABG); percutaneous coronary intervention (PCI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• alive participants of underlying study who do not consent

Sponsors & Collaborators

• Heart Center Leipzig - University Hospital: lead

Study Sites (4)

Universitäts-Herzzentrum Freiburg Bad Krozingen

Bad Krozingen, Baden Würtemberg, 79189, Germany

Location

Klinikum der Ludwig-Maximilians Universität München

München, Bavaria, 80336, Germany

Location

München Klinik Neuperlach

München, Bavaria, 81737, Germany

Location

Heart Center Leipzig at University of Leipzig

Leipzig, Saxony, 04289, Germany

Location

MeSH Terms

Conditions

Coronary Stenosis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Steffen Desch, MD

  Heart Center Leipzig at University of Leipzig

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: July 27, 2023
• Study Start: January 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

DE (4)