Coronary StenosisNCT05963620
Long-term Follow-up of a Randomized Comparison of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Surgery
An observational study of Coronary Stenosis and Coronary Artery Disease, run by Heart Center Leipzig - University Hospital at 4 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Stenosis, Coronary Artery Disease
- What is being tested?
- percutaneous coronary intervention vs bypass graft surgery
- How many people
- 201 participants
- Where
- 4 sitesGermany
- Study dates
- 1 Jan 2023to Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- alive participants of underlying study who give their consent to participate
- deceased participants of underlying study
Who cannot join
- alive participants of underlying study who do not consent
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, Baden Würtemberg, 79189
Heart Center Leipzig at University of Leipzig
Leipzig, Saxony, 04289
Klinikum der Ludwig-Maximilians Universität München
München, Bavaria, 80336
München Klinik Neuperlach
München, Bavaria, 81737
About this study
Official title: Long-term Follow-up of a Randomized Comparison of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Surgery in Unprotected Left Main Disease
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.
Read the 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
- Coronary Stenosis, Coronary Artery Disease
- Being tested
- percutaneous coronary intervention vs bypass graft surgery
- Keywords
- Percutaneous coronary intervention, sirolimus-eluting stent, coronary artery bypass grafting
- Medical subject headings
- Coronary Stenosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary intervention vs bypass graft surgeryOther
retrieve long term follow up data on clinical outcome of study population, no intervention
| Study group | Role | What they receive |
|---|---|---|
| percutaneous coronary intervention (PCI) | percutaneous coronary intervention (PCI) with sirolimus-eluting stents Receives: Other: percutaneous coronary intervention vs bypass graft surgery | |
| coronary artery bypass grafting (CABG) | coronary artery bypass graft surgery Receives: Other: percutaneous coronary intervention vs bypass graft surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death
further categorized into cardiovascular, noncardiovascular, and undetermined deaths
Measured: approximately 15 years after procedure
Secondary outcomes (1)
composite secondary endpoint
all-cause death, myocardial infarction or repeat target vessel revascularization
Measured: approximately 15 years after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Jan 2023
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart Center Leipzig - University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steffen Desch, MD, Study chair, Heart Center Leipzig at University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963620
- Sponsor's protocol ID
- 2021-0444
- Status last verified
- Jul 2023
- First submitted
- 19 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of a Randomized Comparison of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Surgery in Unprotected Left Main Disease
- ClinicalTrials.gov ID
- NCT05963620
- Acronym / sponsor ID
- 2021-0444
- Conditions
- Coronary Stenosis, Coronary Artery Disease
- Keywords
- Percutaneous coronary intervention, sirolimus-eluting stent, coronary artery bypass grafting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- Heart Center Leipzig - University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| percutaneous coronary intervention (PCI) | – | Other: percutaneous coronary intervention vs bypass graft surgerypercutaneous coronary intervention (PCI) with sirolimus-eluting stents |
| coronary artery bypass grafting (CABG) | – | Other: percutaneous coronary intervention vs bypass graft surgerycoronary artery bypass graft surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- alive participants of underlying study who give their consent to participate
- deceased participants of underlying study
Key exclusion criteria (1 listed)
- alive participants of underlying study who do not consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous coronary intervention vs bypass graft surgeryretrieve long term follow up data on clinical outcome of study population, no intervention | Other | coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI) |
Primary outcome
All-cause death
Time frame: approximately 15 years after procedure
further categorized into cardiovascular, noncardiovascular, and undetermined deaths
1 secondary outcome
composite secondary endpoint
Time frame: approximately 15 years after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffen Desch, MD study chair
Heart Center Leipzig at University of Leipzig
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Stenosis and Coronary Artery Disease, run by Heart Center Leipzig - University Hospital at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause death (time frame: approximately 15 years after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.