Palpitate-Eluting Balloon Angioplasty in the Treatment of Coronary Bifurcation Lesion Evaluated by OCT — PEBCBLO  

Percutaneous Coronary Intervention Clinical Trial

Official title: Palpitate-Eluting Balloon Angioplasty in the Treatment of Coronary Bifurcation Lesion Evaluated by OCT

Status Recruiting

Clinical Trial Summary

The aim of the study is to use optical coherence tomography (OCT) to investigate the efficacy of Paclitaxel-eluting PTCA-balloon dilation (SeQuent Please) in SB and drug eluting stent (EXCEL stent) deployment in the main branch (reference diameter: ≥ 2.5 mm and ≤ 4.0 mm, reference diameter of side branch: ≥ 2.0 mm and ≤ 3.5 mm, length of stenoses in either branch ≤ 30 mm) in the treatment of significant (>70%) de-novo-bifurcation stenoses of any Medina classification type in the native coronary artery as reflected by procedural success and to evaluate the preservation of vessel patency.

Clinical Trial Description

Catheter interventions of coronary lesions involve a bifurcation in 15-20%. The treatment of bifurcation lesions is usually more difficult as compared to non-bifurcation lesions and the complication rate is higher. Possible complications are acute SB closure (BBC one) and higher rates of restenosis and stent thrombosis. Carina shifting after stenting ,double or triple layers of stents, stent distortion and different tissue distribution may be the reasons. The use of drug-eluding stents in the treatment of bifurcation lesions suggests that DES reduces the rate of restenosis int he main branch (5-10%); however, results in the side branch are not optimal. Current interventional treatment of most bifurcation lesions consists in implanting a DES in the MB with POBA and provisional T-stenting of the SB. Drug eluting Balloon is the new options and improvements in the field of coronary angioplasty. Clinically proven, it offers completely new procedural options to treat vascular stenoses since the drug elution does not require a stent platform. Since the SB is rarely stented, the DEB could be particularly helpful to reduce the restenosis rate of a SB lesion. PEPCAD V trial has proved Percutaneous treatment of bifurcation lesions with a drug-eluting balloon resulted in a procedural success of 100%. Follow-up angiography at nine months showed DES-like results in MB and SB. In PEPCAD V trial，the MB was dilated with a DEB. Next, a BMS (CoroflexR, B. Braun Melsungen AG, Germany) was implanted in the MB. While the procedure is complex, whether we can put drug eluting stent in MB directly and this overlap of drug delivery is harmful. OCT system had an axial resolution of 20 microm and a transverse resolution of 30 microm. OCT was able to penetrate and image near-occlusive coronary plaques. Therefore, it is prudent to use OCT to investigate the efficacy of Paclitaxel-eluting PTCA-balloon dilation (SeQuent Please) in SB and drug eluting stent (EXCEL stent) deployment in the main branch (reference diameter: ≥ 2.5 mm and ≤ 4.0 mm, reference diameter of side branch: ≥ 2.0 mm and ≤ 3.5 mm, length of stenoses in either branch ≤ 30 mm) in the treatment of significant (>70%) de-novo-bifurcation stenoses of any Medina classification type in the native coronary artery as reflected by procedural success and to evaluate the preservation of vessel patency. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Angioplasty
• Percutaneous Coronary Intervention

• NCT number: NCT02276846
• Study type: Observational [Patient Registry]
• Source: Second Hospital of Jilin University
• Contact: Liu Bin, M.D.
• Phone: +86 13500810268
• Email: liubin3333@vip.sina.com
• Status: Recruiting
• Phase: N/A
• Start date: October 2014
• Completion date: December 2015