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

October 27, 2014 updated by: Liu Bin, Second Hospital of Jilin University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130041
        • Recruiting
        • The Second Hospital of Jilin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
In-segment late lumen loss
Time Frame: 9 months
In-segment late lumen loss in the side branch and main branch evaluated by OCT
9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
major adverse cardiac events (MACE)
Time Frame: 9 months
cardiac death, myocardial infarction and target lesion revascularization
9 months
Procedural success
Time Frame: 10 minutes
a stenosis ≤30% in the MB and ≤50% in the SB along with TIMI III flow
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SecondJilinU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings