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

• ClinicalTrials.gov Identifier: NCT02276846
• Recruitment Status: Unknown
• First Posted: October 28, 2014
• Last Update Posted: October 28, 2014
• Sponsor: Second Hospital of Jilin University
• Information provided by (Responsible Party): Liu Bin, Second Hospital of Jilin University

Study Description

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.

Condition or disease	Intervention/treatment
Angioplasty; Percutaneous Coronary Intervention	Device: Paclitaxel-Eluting Balloon

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.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 30 participants
• Time Perspective: Prospective
• Target Follow-Up Duration: 9 Months
• Official Title: Palpitate-Eluting Balloon Angioplasty in the Treatment of Coronary Bifurcation Lesion Evaluated by OCT
• Study Start Date: October 2014
• Estimated Primary Completion Date: January 2015
• Estimated Study Completion Date: December 2015

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. major adverse cardiac events (MACE) [ Time Frame: 9 months ]
   cardiac death, myocardial infarction and target lesion revascularization
2. Procedural success [ Time Frame: 10 minutes ]
   a stenosis ≤30% in the MB and ≤50% in the SB along with TIMI III flow

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

This study is designed for 25 subsequent patients with coronary heart disease to complete the study per protocol. Eligible patients shall exhibit a bifurcational lesion in the native left coronary artery (reference diameter LAD or LCx: 2.5 mm -4.0 mm, length of stenosis: ≤30 mm, reference diameter D1/D2 or OMS1/OMS2: 2.0 mm-3.5 mm, length of stenosis: ≤ 30 mm) in need of percutaneous coronary intervention. Eligible patients may have single or multivessel coronary artery disease.

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.

Inclusion Criteria: Lesion Related

• De-novo bifurcational native left coronary artery lesion (reference diameter LAD or LCx:2.5 mm-4.0 mm, length of stenosis: ≤30 mm, reference diameter D1/D2 or OMS1/OMS2:2.0 mm -3.5 mm, length of stenosis: ≤30 mm)
• Diameter stenosis pre procedure must be either 70 % in either one or both branches of the lesion (i.e. bifurcational lesion of any type of the Medina classification) or 50 % if ischemia corresponding to the target lesion is documented either by exercise stress ECG, stress echocardiography, scintigraphy, MRT, or suspected based on angina pectoris
• Single or multi-vessel coronary artery disease

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
• Patients with bleeding diathesis in whom anticoagulation or anti-platelet medication is contraindicated
• Patients who had a cerebral stroke <6 months prior to the procedure
• Patient participates in other clinical trials involving any investigational device or drug
• Untreated hyperthyroidism
• Patient has presence or history of severe renal failure (GFR<30ml/min, "Cockcroft Gault") and is therefore at high risk for angiography associated renal complications. Patient's serum creatinine levels must be documented
• Post transplantation of any organ or immune suppressive medication
• Other disease to jeopardize follow-up (e.g,malignancy)
• Addiction to any drug or to alcohol
• Patients with any type of surgery during the week preceding the interventional procedure.
• Therapy with anticoagulants
• After PTCA,Coronary artery dissection appears Exclusion Criteria: Lesion Related
• Evidence of extensive thrombosis within target vessel before the intervention
• Multilesion percutaneous coronary intervention beside the bifurcation lesion in the left coronary artery (no other intervention is admitted during the same procedure)
• Patients with another coronary stent implanted previously into the target vessel ≤15 mm distant to the current lesion, drug eluting stents less than 9 months and bare metal stents or stents with passive coatings less than 3 months before the PEBCBLO
• Target lesion located in any type of coronary bypass (i.e,venous graft, arterial bypass) or graft/native artery connection
• Coronary artery occlusion of any type (e.g, acute or chronic)
• In-stent restenosis
• In-segment restenosis of the native vessel within 4 mm adjacent to the target lesion Exclusion Criteria Related to Concomitant Medication
• Patient is intolerant to aspirin and/or the ADP-antagonists clopidogrel/ticlopidine or has a history of neutropenia, thrombocytopenia induced by ADP-antagonists, or severe hepatic dysfunction prohibiting the use of clopidogrel

Contacts and Locations

Contacts

Contact: Liu Bin, M.D.; +86 13500810268; liubin3333@vip.sina.com

Locations

China, Jilin

The Second Hospital of Jilin University; Recruiting

Changchun, Jilin, China, 130041

Contact: Liu Bin, M.D. +86 13500810268 liubin3333@vip.sina.com

Sponsors and Collaborators

Second Hospital of Jilin University

More Information

Additional Information:

• Responsible Party: Liu Bin, M.D.Professor Director of Cardiology Department, Second Hospital of Jilin University
• ClinicalTrials.gov Identifier: NCT02276846
• Other Study ID Numbers: SecondJilinU
• First Posted: October 28, 2014
• Last Update Posted: October 28, 2014
• Last Verified: October 2014

Keywords provided by Liu Bin, Second Hospital of Jilin University:

Palpitate-Eluting Balloon; Bifurcation; OCT; Transluminal

Additional relevant MeSH terms:

Paclitaxel; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action