An observational study in Coronary Stenosis and Coronary Artery Disease, sponsored by Heart Center Leipzig - University Hospital. Enrolling by invitation at 4 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Heart Center Leipzig - University Hospital · Observational
Among 46 studies in Coronary Stenosis with a site in Germany — 6 open to participants now, 9 under way, none of them phase 3. Coronary Stenosis · Germany.
Among the 46 studies in Coronary Stenosis with a site in Germany, this one is the 8th largest by planned enrollment of the 14 observational ones that give a count, is the only one that started in 2023, is one of 14 observational ones, and was the 45th registered.
326 studies on the registry are indexed under Coronary Stenosis; 57 are open to participants now.
This study's planned enrollment of 201 is close to the median of 200 across 125 observational studies indexed under Coronary Stenosis.
Browse Coronary Stenosis studies →6 of the 46 studies in Coronary Stenosis with a site in Germany are open now.
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 40 Coronary Stenosis studies recruiting now, 33 (83%) set no upper age limit and 3 (8%) stop at 75 or younger; 4 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →46 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 5 · Phase 3 5 · Phase 4 7
First in 2003; this study’s year is marked. 1 started in 2023.
Median enrollment 215 across the 32 interventional studies, 219 across the 14 observational. Of the 28 that completed or were terminated, 6 (21%) have results posted.
23 of 46 have an industry lead sponsor. The 10 most frequent:
Heart Center Leipzig - University Hospital is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
Heart Center Leipzig - University Hospital has 1 study filed under Coronary Stenosis — fewer than ten, so there is no comparison to draw.
1 of the studies in Coronary Stenosis with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03820492Insel Gruppe AG, University Hospital BernComparison of Optical Coherence Tomography-derived Minimal Lumen Area, Invasive Fractional Flow Reserve and FFRCT | 2026-12-31 |
Among the 46 studies in Coronary Stenosis with a site in Germany, from their registry updates:
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.
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.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
percutaneous coronary intervention (PCI) with sirolimus-eluting stents
Other: percutaneous coronary intervention vs bypass graft surgery
coronary artery bypass graft surgery
Other: percutaneous coronary intervention vs bypass graft surgery
retrieve long term follow up data on clinical outcome of study population, no intervention
All-cause death
further categorized into cardiovascular, noncardiovascular, and undetermined deaths
Time frame: approximately 15 years after procedure
composite secondary endpoint
all-cause death, myocardial infarction or repeat target vessel revascularization
Time frame: approximately 15 years after procedure
Started Jan 2023 (actual). Primary completion is estimated for Feb 2024, 13 months after the start.
Of 58 observational studies under Coronary Stenosis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 143. This study's planned 13 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Heart Center Leipzig - University Hospital