Trials / Unknown
UnknownNCT05963620
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 201 (estimated)
- Sponsor
- Heart Center Leipzig - University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | percutaneous coronary intervention vs bypass graft surgery | retrieve long term follow up data on clinical outcome of study population, no intervention |
Timeline
- Start date
- 2023-01-01
- Primary completion
- 2024-02-01
- Completion
- 2024-02-01
- First posted
- 2023-07-27
- Last updated
- 2023-07-27
Locations
4 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT05963620. Inclusion in this directory is not an endorsement.