Clinical Efficacy and Safety of a Prospective, Multicenter Drug Coated Balloon for Left Main Artery Disease in China

November 23, 2020 updated by: Xuzhou Third People's Hospital
This is a prospective and observational study. Patients with primary mediana 010 or 001 left main bifurcation lesions were treated with drug ball coated balloon from November 2018 to November 2020 in four hospitals in Huaihai area. The clinical characteristics, pathological changes, operation process and perioperative drug treatment data were collected. Clinical follow-up included hospitalization, postoperative telephone or outpatient follow-up. Objective to compare the safety and efficacy of drug-eluting balloon and drug-eluting stent implantation alone in the treatment of primary mediana 010 or 001 left main bifurcation lesions.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

At present, the primary left main trunk end bifurcation lesions with mediana classification of 010 or 001 are mainly treated by crossing stent technique or direct precise positioning stent technology. Because of the difficulty of precise stent placement, the displacement of cristae across stent implantation is easy to affect the distal vessels of the side branch or main branch, and the long-term clinical efficacy is not good, so the standardized interventional therapy is still controversial. Recently, a registered study published by regatelli et al. Showed that spanning stent technology seems to be superior to precise positioning stent technology, but the major adverse cardiac event rate in clinical follow-up is high.

Drug coated balloon (DCB) as a new interventional therapy in recent years, has been gradually used in the treatment of primary coronary artery disease in situ. The latest international consensus on the treatment of coronary heart disease with DCB indicates that more and more clinical studies have shown the safety and effectiveness of DCB in the treatment of coronary artery disease (≥ 3.0 mm). However, there are few studies on the interventional therapy of DCB in the primary mediana type 010 or 001 left trunk end bifurcation lesions, especially the combination of "1-2mm" drug-eluting stent (DES) implantation when necessary.

The purpose of this study was to investigate the feasibility and short-term clinical efficacy of DCB combined with DES implantation in the treatment of primary mediana 010 or 001 left main bifurcation lesions, and to explore a new treatment for such lesions.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

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 Backup

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221000
        • Recruiting
        • Xuzhou Third People's Hospital
        • 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

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or non pregnant women aged 18-75 years old;
  2. There is clear evidence of myocardial ischemia, including typical ECG changes, non ST segment elevation acute coronary syndrome, ST segment elevation acute myocardial infarction, etc;
  3. For mediana 010 or 001 confirmed by coronary angiography, the stenosis was more than 70% by visual inspection and less than 30% at the end of left main artery;
  4. They can receive DCB treatment;
  5. The reference vessel diameter was 2.00 ~ 4.00 mm;
  6. To understand the potential risk of operation and have the intention of DCB treatment.

Exclusion Criteria:

  1. Hemodynamic instability, unable to tolerate surgery;
  2. The left ventricular ejection fraction was less than 35%;
  3. Contrast medium allergy or contraindication for secondary prevention of coronary heart disease;
  4. Stents were implanted in the left main trunk;
  5. Severe renal insufficiency (EGFR ≤ 30 ml / min / 1.73 m2);
  6. Severe infection;
  7. Life expectancy is less than one year. All patients signed the informed consent of interventional therapy before operation, and this study was approved by hospital ethics committee.

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

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Mediana 010 or 001 left main bifurcation lesion
DCB alone combined with retracted DES implantation if necessary (d-p-d strategy)
Procedure: DCB
OCT technical guidance: if B-type or C-type dissection can be seen, Oct should be used for further evaluation, and des treatment should be conducted if necessary
Other Names:
  • optical coherence tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The patients were followed up for 12 months to observe the major adverse cardiac events (MACE)
Time Frame: 12 months after operation
There were three endpoints: cardiovascular death, myocardial infarction and stroke
12 months after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of target lesion revascularization
Time Frame: 12 months after operation
Target lesion revascularization
12 months after operation
All revascularization rates
Time Frame: 12 months after operation
All revascularization
12 months after operation

Collaborators and Investigators

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

Sponsor

Xuzhou Third People's Hospital

Investigators

  • Principal Investigator: yaojun zhang, doctor, Head of Cardiology Department of Xuzhou Third People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

November 1, 2018

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

November 17, 2020

First Submitted That Met QC Criteria

November 17, 2020

First Posted (ACTUAL)

November 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-02-002-K01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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