Coronary Artery Disease Clinical Trial
— HREVSOfficial title:
Prospective, Single-center, Randomized Trial, Intended to Compare Three Revascularization Strategies in Patients With Multi-vessel Coronary Artery Disease
Verified date | September 2017 |
Source | Russian Academy of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Minimally invasive revascularization of the left anterior descending artery followed by stent implantation versus percutaneous coronary intervention or coronary artery bypass in patients with multi-vessel coronary disease
Status | Completed |
Enrollment | 150 |
Est. completion date | September 16, 2017 |
Est. primary completion date | March 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Multi-vessel coronary artery disease with = 70% and <96% artery stenosis (according to QCA) 2. I-IV CCS functional class of angina 3. Asymptomatic patients with stress-test documented ischemia. 4. Patients at 1 month after acute myocardial infarction 5. Ability to perform either of revascularization methods (Hybrid, MVD-PCI, CABG). 6. Consensus on the treatment strategy between the members of the working group, including cardiologist, cardiac surgeon and interventional specialist. 7. Patients must have signed an informed consent. Exclusion Criteria: 1. Pregnancy. 2. Acute coronary syndrome. 3. Previous CABG. 4. Previous stent thrombosis. 5. Severe comorbidity with high procedural risk for either of the studied strategies. 6. Severe peripheral artery disease. 7. Other serious diseases limiting life expectancy (e.g. oncology) 8. Inability for long-term follow-up. 9. Participation in other clinical trials. 10. Inability to take dual antithrombotic therapy. Angiographic exclusion criteria 1. Critical stenosis (>95%) in RCA,LAD, CX or Intermediate artery, feasible for revascularization. 2. Stenosis of left main = 50%. 3. Coronary artery occlusion of the major vessel. 4. Single vessel disease. 5. Need for emergency revascularization (ACS). |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Research Institute of Complex Issues of Cardiovascular Diseases | Kemerovo | Kemerovo region |
Lead Sponsor | Collaborator |
---|---|
Russian Academy of Medical Sciences |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Residual ischemia | =5% residual ischemia by single photon emission computed tomography (SPECT) | 6 - to 18-month follow-up | |
Secondary | MACCE | Major adverse cardiac and cerebral events (MACCE), including death,a composite of major cardiac and cerebrovascular events, i.e. the first occurrence of any of the following events: Death from any cause From cardiovascular causes From noncardiovascular causes Stroke or transitory ischemic attack (TIA) MI Hospitalization for repeat revascularization procedure, target (vessel) revascularization by means of PCI or CABG. |
up to 5 years | |
Secondary | Procedural success | Procedural success: The treatment will be considered successful when a complete hybrid revascularisation in the absence of complications during the index hospitalization has been achieved. | up to discharge from the hospital | |
Secondary | Procedural and post-procedural blood loss and number of transfusions | dynamics of hemoglobin at admission and discharge, the number of blood transfusions (in units), classification of bleeding BARC | up to discharge from the hospital | |
Secondary | Recovery time | Time Frame: from the end of the intervention up to discharge from the hospital. Total duration of hospital admission | up to discharge from the hospital | |
Secondary | Target vessel/graft failure | (for any of the target vessels in a given patient - stented or grafted) = a composite of cardiac death, MI attributable to the target vessel, or clinically-driven [ie, not angio-driven] Target Vessel Revascularization (TVR); | 6- to 18-month follow-up | |
Secondary | Restenosis | angiographically-detected target lesion stenosis >50% [diameter stenosis] or graft stenosis >50%; | 6- to 18-month follow-up |
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