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NCT Number: NCT05368597

CompArison of PCI in NaTive Arteries Versus ByPAss Grafts In PatieNts With Prior CABG (CAPTAIN)

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients received first percutaneous coronary intervention in native arteries or in bypass grafts after coronary artery bypass grafting

Exclusion criteria

  • Patients who missed follow-up data were excluded

Treatment and study plan

PCI in native vessel or in bypass graft

Procedure

Native vessel PCI,which choose native coronary artery as the target vessel, while the bypass graft PCI choose graft vessel as the target vessel.

Primary outcomes

  1. Major adverse cardiovascular event (MACE)

    Time frame: about 10 years after PCI

    A composite of all-cause death, non-fatal stroke, non-fatal myocardial infarction

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Official study title

Comparison of Percutaneous Coronary Intervention in Native Arteries Versus Bypass Grafts in Patients With Prior Coronary Artery Bypass Grafting

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 10, 2022
Registry last updated
May 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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