CompArison of PCI in NaTive Arteries Versus ByPAss Grafts In PatieNts With Prior CABG (CAPTAIN)
Comparison of Percutaneous Coronary Intervention in Native Arteries Versus Bypass Grafts in Patients With Prior Coronary Artery Bypass Grafting
1 other identifier
observational
1,491
1 country
1
Brief Summary
Coronary atherosclerotic heart disease (CAD) has been considered the leading cause of death in both developed and developing countries. Coronary artery bypass grafting (CABG) is a major therapy of CAD in the world, mainly used for patients with left main disease, multi-vessel complex disease, stent implantation failure, heart failure and diabetes. Studies have demonstrated that significant angiographic defects up to 12% of grafts, which was observed by immediate coronary angiography after CABG. Despite secondary prevention were performed in patients after CABG, the early failure rate at 1 year is higher, up to 15-20%, the 10-year patency rate of internal mammary artery graft is 85%, and the 10-year patency rate of saphenous vein graft is only 61%, and 10-20% of patients require revascularization within 10 years after CABG. Patients with failed grafts usually have a higher surgical risk and the morality of repeat CABG is 2-4 times higher than primary surgery. Because of the poor clinical prognosis of patients undergoing repeat CABG, PCI is the preferred treatment strategy for revascularization in patients with previous CABG. In patients with previous CABG, approximately 75% of PCI target vessels are native vessels. Compared with native vessel PCI, bypass graft PCI has a higher rate of short- and long-term major adverse events, including more than double the in-hospital mortality rate. Some studies support the above view，but others denied. Therefore, the primary study mainly to explore the effect of native vessel PCI or graft PCI on the prognosis of patients with previous CABG.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedFirst Submitted
Initial submission to the registry
May 6, 2022
CompletedFirst Posted
Study publicly available on registry
May 10, 2022
CompletedMay 16, 2022
May 1, 2022
2.5 years
May 6, 2022
May 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major adverse cardiovascular event (MACE)
A composite of all-cause death, non-fatal stroke, non-fatal myocardial infarction
about 10 years after PCI
Study Arms (2)
Native vessel PCI
Native vessel PCI, which choose native coronary artery as the target vessel
Bypass graft PCI
Bypass graft PCI, which choose the graft vessel as the target vessel
Interventions
Native vessel PCI,which choose native coronary artery as the target vessel, while the bypass graft PCI choose graft vessel as the target vessel.
Eligibility Criteria
Coronary artery disease patients received first percutaneous coronary intervention in native arteries or in bypass grafts after coronary artery bypass grafting
You may qualify if:
- Patients received first percutaneous coronary intervention in native arteries or in bypass grafts after coronary artery bypass grafting
You may not qualify if:
- Patients who missed follow-up data were excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhijian Wang
Beijing Anzhen Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
May 6, 2022
First Posted
May 10, 2022
Study Start
October 1, 2019
Primary Completion
April 1, 2022
Study Completion
May 1, 2022
Last Updated
May 16, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share