Drug-coated Balloon Clinical Trial
Official title:
Prospective Clinical Research on Safety and Efficacy of Drug Coated Balloon in de Novo Coronary Lesion With Diameters Larger Than 2.75 mm Under OCT Guidance
Intro-stent restenosis, bifurcation lesions and small vascular lesion with diameter <2.75mm is the indication of drug coated balloon. In the era of traditional coronary artery balloon dilatation, it is believed that muscle fiber of coronary artery great vessels is more abundant than that of small vessels, and elastic recoil and dissection are easier to appear upon dilatation, which will result in acute vascular occlusion and restenosis, so it is not recommended for great vessels to only receive PTCA therapy. But for patients with good angiography result without combination of serious dissections after predilation, the acute thrombosis seems to be a key factor for acute vascular occlusion. Traditional antiplatelet drug doesn't have a good effect, but the application of new-generation antiplatelet drug (clopidogrel, ticagrelor and tirofiban) has greatly reduced the occurrence rate of acute thrombosis. Therefore, under the guarantee of fully antiplatelet action of new-generation antiplatelet drug, for the patients with good angiography result without combination of serious dissections after predilation, Drug coated balloon seems to be an alternative of the stent. This research is to verify the safety and efficacy of Drug coated balloon in de novo coronary artery lesion with vascular diameter ≥2.75mm.
Status | Not yet recruiting |
Enrollment | 45 |
Est. completion date | April 2019 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria - At the age of 18-80 (18 and 80 included) - The female at reproductive age shouldn't get pregnant or plan to get pregnant during the research - Patients must agree to accept 3-month angiography follow-up - Patients must agree to accept clinical follow-up on 30-day, 60-day and 90-day after operation - Psychologically and linguistically, patients could have an understanding of the research purpose, revealing sufficient compliance with the research proposal. The patients' provision of the informed consent represents that the patient accepts the risks and benefits described in the informed consent. - Target lesion diameter stenosis is =50%, and reference vascular diameter is =2.75mm - De novo coronary lesion - Type A lesion Exclusion criteria - Patients with myocardial infarction within one week - Patients with congestive heart failure or severe NYHAIV heart failure - Patients with severe valvular heart disease - The female in pregnancy or lactation period - Patients whose life expectancy don't exceed 1 year or who might have difficulty in clinical follow-up - Patients who are of bleeding physique or forbidden to administer anticoagulants or antiplatelet drugs - Patients who suffered from cerebral stroke within 6 months prior to surgery - Patients who are involved in any other clinical trials - Patients who fail to satisfy angiography conditions due to currently suffering from or previously undergoing severe renal failure (GFR<30ml/min) - Patients who underwent heart transplantation - Patients who are deemed inappropriate for inclusion by the researcher due to other reasons - Lesion of left main coronary artery - Double vessel or triple vessel disease needed to be interventional treated - Double vessel or triple vessel disease needed to be interventional treated - Patients who are intolerant of aspirin and/or clopidogrel, have the medical history of neutrocytopenia or thrombocytopenia, or are forbidden to administer clopidogrel due to severe hepatic insufficiency - Patients with known hypersensitivity - Patients with the history of leukopenia (white blood cell count<3x109/L for over 3 days), or neutrocytopenia (ANCs <1,000 neutrophils/mm3 for over 3 days) or thrombocytopenia (blood platelets<100,000/mm3) - Patients having the history of peptic ulcer or gastrointestinal bleeding within the past 6 months |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Second Hospital of Jilin University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lumen loss in advanced stage of lesion segments within 3 months | Lumen loss in advanced stage of lesion segments within 3 months | 3 months | |
Secondary | Success rate of interventional therapy (including device success rate, lesion success rate and clinical success rate) | 3 months | ||
Secondary | Occurrence rate of dissection after procedure | 3 months | ||
Secondary | Binary restenosis rate 3 months after procedure | 3 months | ||
Secondary | Cardiovascular clinical composite endpoints related to device at the time of 30 days, 60 days and 90days after the surgery include cardiac death, target vessel myocardial infarction and target lesion revascularization driven by clinical symptoms, | 3 months | ||
Secondary | Cardiovascular clinical composite endpoints related to patients at the time of 30 days, 60 days and 90 days after the surgery include all-cause mortality, all myocardial infarction and any revascularization | 3 months | ||
Secondary | ARC-defined occurrence rate of thrombotic events (identified, probable and non-excluded thrombosis during acute, subacute and advanced stage) | 3 months |
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