NCT03223974

Clinical Trial on Safety and Efficacy of Drug-coated Balloon in Treatment of Coronary Bifurcation Lesions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Beijing Hospital · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and efficacy of paclitaxel-coated balloon in treatment of coronary bifurcation lesions. This is a feasible study to demonstrate the noninferiority of paclitaxel Drug-coated balloon(DCB) only strategy for bifurcation lesions when compared with traditional single drug eluting stent(DES) strategy, so as to simplify the procedure for treatment of coronary bifurcation lesions and extending the clinical indications of paclitaxel DCB in China.

Detailed description

Paclitaxel DCB is designed to release anti-proliferative agents to the whole lesion rapidly and homogenously to inhibit excessive neointima proliferation and is associated with rapid healing of endothelium. As a result, DCB therapy reduces the risk of coronary thrombosis. Since only 1 to 3 months duration of dual anti-platelet therapy is required, the bleeding risk associated with prolonged dual anti-platelet therapy (DAPT) is reduced by DCB. Furthermore, there is no permanent residue of foreign bodies in the blood vessels after DCB procedure and this advantage completely eliminates adverse events associated with allergic reactions to metal, polymer and stent fracture. For side branch(SB) with a relatively small lumen in bifurcation lesions, DCB may neglect the lumen loss due to stent scaffolds and cause much less late lumen loss (LLL) than stent therapy does. For main branch(MB), no jailed SBs by the stent and the rate of SB stenosis or even occlusion will be greatly reduced.

Conditions

• Coronary Disease

Interventions

Type	Name	Description
DEVICE	Paclitaxel DCB	Balloon/vessel diameter ratio 0.8-1.0, 8-10 ATM, lasting for \>30 seconds. If quantitative coronary angiography determines residual stenosis ≤ 30% , it is considered to be a successful operation.
DEVICE	DES	MB should be sufficiently predilated to facilitate the positioning of the stent and the stent residual stenosis should be ≤10% to be a successful operation.

Timeline

• Start date: 2017-11-16
• Primary completion: 2019-11-30
• Completion: 2021-02-28
• First posted: 2017-07-21
• Last updated: 2022-03-22

Locations

1 site across 1 country: China