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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05101005 -
Long-term Efficacy of Drug-coated Balloon Versus Drug-eluting Stent in Large de Novo Coronary Lesions
|
N/A | |
Recruiting |
NCT06084000 -
STrategies of Scheduled Drug-coated Balloons (DCB) Versus Conventional DES for the interveNTional Therapy of de Novo Lesions in Large Coronary vESSels (STENTLESS) Trial
|
N/A | |
Recruiting |
NCT03360279 -
DCB for Dialysis Access Stent Graft Restenosis
|
N/A | |
Completed |
NCT04234893 -
Bingo Drug-Coated Balloon in Real World
|
||
Not yet recruiting |
NCT06265324 -
Drug-coated Balloon Treatment in Coronary Lesions
|
N/A | |
Active, not recruiting |
NCT04826705 -
A Study of Endovascular Treatment of Femoropopliteal Arterial Occlusive Lesion With Drug-Coated Balloon
|
||
Completed |
NCT04984135 -
DCB Angioplasty for Coronary Lesions: an OCT Analysis
|
||
Recruiting |
NCT05562089 -
Prevail Drug Balloon Study
|
N/A | |
Recruiting |
NCT04619277 -
Impact of Drug-coated Balloon Treatment in de Novo Coronary Lesion
|
||
Active, not recruiting |
NCT04937803 -
Safety and Efficacy of Drug-Coated Balloon for De-novo Lesions in Patients With Acute Coronary Syndromes (DCB-ACS)
|
N/A | |
Not yet recruiting |
NCT04778969 -
Kor PCI - CAD Patients Treated With PCI: Analysis of the Korean Nationwide Health Insurance Database
|