NCT01035034

Comparison of One-stop Hybrid Revascularization Versus Percutaneous Coronary Intervention for the Treatment of Multi-vessel Disease

Comparison of "One-stop" Hybrid Coronary Revascularization Versus Percutaneous Coronary Intervention for the Treatment of Multi-vessel Coronary Artery Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The "one-stop" hybrid coronary revascularization combines minimally invasive direct coronary artery bypass (MIDCAB) and PCI to be performed in the hybrid operating suite, an enhanced operating room equipped with radiographic capability. This study is to compare 1-year clinical outcomes of "one-stop" hybrid coronary revascularization with percutaneous coronary intervention (PCI) in selected patients with multivessel coronary artery disease.

Detailed description

Rationale and purpose of this study: "One-stop" (also named simultaneous) hybrid coronary revascularization has emerged as a novel, safe and feasible minimally invasive approach in selected patients with multivessel coronary artery disease (CAD). The benefits of "one-stop" hybrid procedure compared with conventional PCI are unclear, however. This study is a single center randomized clinical trial to compare the safety and efficacy of "one-stop" hybrid procedure with conventional PCI in the treatment of selected patients with multivessel CAD requiring revascularization with suitable coronary anatomy. Sample size: We examined the results of SYNTAX trial and of the hybrid procedures published previously. The 1-year MACCE rate (the primary endpoint) is estimated as being 18% for PCI/stenting and 8% for the hybrid group. The sample calculated for this trial is 480 patients. Design/Methodology: Trial design: A single center randomized clinical trial comparing "one-stop" hybrid procedure versus conventional PCI with SES in 480 patients with suitable anatomy who need revascularization. Intervention: Patients will be randomized to undergo either "one-stop" hybrid procedure or conventional PCI with SES. Randomization: Patients will be evaluated by both a cardiac surgeon and an interventional cardiologist. After obtaining informed written consent, patients will be randomized to receive "one-stop" hybrid procedure or conventional PCI with SES. An expertise-based randomization will be used. The data adjudicators will be blinded to the study. Due to the nature of this study, the operating surgeons, cardiologists, anesthetists, other operative room staff, and ICU staff will not be blind in this study. Study intervention: Candidates will be randomized to receive "one-stop" hybrid procedure or conventional PCI.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	Hybrid MIDCAB/PCI	MIDCAB with no associated or concomitant surgical procedures, using partial ministernotomy, without cardiopulmonary bypass (CPB) and cardioplegia. PCI with drug eluting stents (DES) performed by cardiologists on the non-LAD lesions in the same operating suite immediately following MIDCAB. Device: Polymer-based Sirolimus-Eluting Stents (SES).
PROCEDURE	PCI with DES	Polymer-based Sirolimus-Eluting Stents (SES)

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-12-01
• First posted: 2009-12-18
• Last updated: 2009-12-21

Locations

2 sites across 1 country: China