Palpitate-Eluting Balloon Angioplasty in the Treatment of Coronary Bifurcation Lesion Evaluated by OCT
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Angioplasty
- Sponsor
- Second Hospital of Jilin University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- In-segment late lumen loss
- Last Updated
- 11 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Liu Bin
M.D.Professor Director of Cardiology Department
Second Hospital of Jilin University
Eligibility Criteria
Inclusion Criteria
- •Patient Inclusion Criteria
- •Inclusion Criteria: Patient Related
- •Patients with stable angina pectoris (CCS class 1-3) or with unstable angina pectoris (Braunwald class 1-2, A-C) or documented ischemia or with documented silent ischemia
- •Patients eligible for coronary revascularization by means of PCI
- •Patients must be 18 years of age
- •Women of childbearing potential may not be pregnant nor have the desire to becoming pregnant during the first year following the study procedure. Hence, patients will be advised to use an adequate birth control method up to and including 6-month follow-up
- •Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol
- •Patients must agree to undergo the 9-month angiographic follow-up
- •Patients must agree to undergo the 3-year clinical follow-up
- •Patient is able to verbally acknowledge and understand the associated risks, benefits, and treatment alternatives of this trial. The patients, by providing their informed consent, must agree to these risks and benefits as stated in the patient informed consent document.
Exclusion Criteria
- •Patient Exclusion Criteria
- •Exclusion Criteria: Patient Related
- •Patients with acute (\<24 h) or recent (48 hours) myocardial infarction
- •Patients with unstable angina pectoris (Braunwald class 3)
- •Patients with severe congestive heart failure
- •Patients with severe heart failure NYHA IV
- •Patients demonstrating clinical signs of cardiogenic shock at the time of the procedure (systolic blood pressure of less than 80 mmHg requiring inotropic support, IABP, and/or fluid challenge)
- •Patients with severe valvular heart disease
- •Women who are pregnant or lactating
- •Patients with life expectancy of less than five years or factors making clinical follow-up difficult
Outcomes
Primary Outcomes
In-segment late lumen loss
Time Frame: 9 months
In-segment late lumen loss in the side branch and main branch evaluated by OCT
Secondary Outcomes
- Procedural success(10 minutes)
- major adverse cardiac events (MACE)(9 months)