Last updated on December 2017

Hybrid Coronary Revascularization Trial


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: | Coronary Artery Disease | Myocardial Ischemia | Heart Attack (Myocardial Infarction) | Open Heart Surgery | Heart Disease
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

•Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation (US sites)

•Age ≥ 18 years

•Clinical indication for coronary revascularization that will be determined by both a surgeon and an interventional cardiologist together.

(Coronary anatomy requiring revascularization will be discussed with you during your visit with cardiology to determine eligibility.)

◦Multivessel Coronary Artery Disease (CAD) involving the Left Anterior Descending (LAD) (proximal or mid) and/or Left Main  (ostial, mid-shaft or distal) with at least 1 other epicardial coronary artery requiring treatment (LCX or RCA), OR

◦Single vessel disease involving the LAD and a major diagonal, with both requiring independent revascularization with at least one stent if randomized to HCR and stents for both the LAD and diagonal if randomized to multivessel PCI.

Note: Other inclusions apply as determined by clinical evaluation and angiogram imaging

•Ability to tolerate and no plans to interrupt dual anti-platelet therapy for ≥ 6 months if presentation with stable CAD, or ≥ 12 months if presentation with biomarker positive acute coronary syndrome (ACS)

•Willing to comply with all protocol required follow-up

 

Exclusion Criteria:

•Previous cardiac surgery of any kind, including CABG

•Previous thoracic surgery involving the left pleural space

•Previous LM or LAD stent (a) with evidence of in-stent restenosis or (b) within 1 cm of a qualifying lesion

•Previous PCI of the LM and/or LAD within 12 months prior to randomization

•PCI with bare metal stent (BMS) within 12 months prior to randomization

•Any complication or unsuccessful revascularization with PCI within 30 days prior to randomization.

 

 

Other Details:

 

Participating in a study is a personal decision. Discuss with your family members and doctor before deciding to join a study.  You or your doctor may contact the study research staff to learn more about this study,

NCT0308939

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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