DCB in de Novo Coronary Lesion
- Conditions
- Drug-coated Balloon
- Interventions
- Device: Drug coated balloon
- Registration Number
- NCT03691675
- Lead Sponsor
- Second Hospital of Jilin University
- Brief Summary
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.
- Detailed Description
Stable or unstable angina patients who accept drug coated balloon dilatation therapy with diameter stenosis≥50%, reference diameter≥2.75mm will be enrolled. OCT examination should be carried out after radiography, predilation, Drug coated balloon dilatation and follow-up.
For target lesion, balloon should be used for predilation (the ratio of balloon diameter to vascular diameter being 0.8-1.0:1), and for good predilation effects, high pressure balloon, cutting balloon, dual-wire balloon and spines balloon can be adopted. OCT examination should be carry out after balloon satisfactory predilation. Satisfactory predilation radiography result is residual stenosis≤30%,TIMI 3 flow without major dissections (type C or higher) in NHLBI classification. OCT satisfactory result is residual stenosis≤30% without dissection, or with dissection but the dissection angle is ≤90°. Then carry out DCB balloon dilatation therapy. The ratio of balloon diameter to vascular diameter is 0.8-1.0:1, and both ends of DCB exceed the preprocessing area of lesion for 2-3mm, thus avoiding the occurrence of geographical mismatch. Dilation pressure is 8-10atm, lasting for at least 30s. Each DCB catheter can be used once only.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Drug coated balloon Drug coated balloon Patients with de novo lesion whose radiography showed that target lesion diameter stenosis is ≥50%, reference diameter is ≥2.75mm and who agreed with the Drug coated balloon dilatation therapy
- Primary Outcome Measures
Name Time Method Lumen loss in advanced stage of lesion segments within 3 months 3 months Lumen loss in advanced stage of lesion segments within 3 months
- Secondary Outcome Measures
Name Time Method Success rate of interventional therapy (including device success rate, lesion success rate and clinical success rate) 3 months 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 Occurrence rate of dissection after procedure 3 months 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 Binary restenosis rate 3 months after procedure 3 months ARC-defined occurrence rate of thrombotic events (identified, probable and non-excluded thrombosis during acute, subacute and advanced stage) 3 months