Yao Strategy for the Treatment of de Novo Medina 0,1,0 or 0,0,1 Bifurcation Lesion

March 25, 2024 updated by: Xuzhou Third People's Hospital

Drug-coated Balloon Combined With Provisional Drug-eluting Stent Implantation (Yao Strategy) for the Treatment of de Novo Medina 0,1,0 or 0,0,1 Bifurcation Lesion

Percutaneous coronary intervention for coronary bifurcation lesions represents one of the most challenging procedures in interventional cardiology because of lower angiographic success rate and increased risk of procedural complications. The study is designed to enroll 200 patients with acute or chronic coronary syndromes that meet the indications for intervention and with angiographic confirmed de novo Medina type 0,1,0 or 0,0,1 bifurcation lesion. In view of the potential risks of using DCB alone in the treatment of de novo bifurcation lesions, the following 2 treatment strategies are available. (1) DCB combined with provisional DES implantation 1-2 mm distally to the lesion ostium whenever this was required (DCB+pDES strategy). (2) DES implantation 1-2 mm distally to the lesion ostium followed by DCB (DES+DCB strategy). The primary endpoint was late lumen loss and major adverse cardiovascular events.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects at the age between ≥18 and ≤80 years old;
  2. De novo native lesion, Median type 010/001 bifurcation lesion;
  3. The reference diameter of the target vessel was 2.75-4.0mm and the length was less than 40mm;
  4. Subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up.

Exclusion Criteria:

  1. The diameter stenosis of adjacent branch vessel ostium ≥50%;
  2. Acute ST-segment elevation myocardial infarction;
  3. Stents implanted within 10 mm proximal or distal to the target lesion;
  4. Aneurysm within 10 mm proximal or distal to the target lesion;
  5. There is target vessel distortion or severe calcification lesion, so balloon catheter fails to pass;
  6. Previous coronary artery bypass grafting;
  7. Evidence for extensive thrombus within target vessel;
  8. Evidence of heart failure by at least one of the following: a. Most recent LVEF ≤35%, or b. Current heart failure defined as dyspnea at rest (NYHA class IV assessed day of procedure), or c. Killip class ≥2 (post STEMI patients);
  9. Subjects with a life expectancy of ≤1 year;
  10. Subjects with stroke, peptic ulcer, or gastrointestinal bleeding within the past 6 months;
  11. Subjects with severe renal failure (eGFR<30ml/minute), failure to comply with angiography conditions;
  12. Subjects who are intolerance to aspirin and/or clopidogrel or ticagrelor or have contraindications;
  13. Subjects who are intolerance or allergic to heparin, contrast agent;
  14. Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;
  15. Subjects who are not applicable to be enrolled by investigators due to other reasons.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yao technique
The following 2 treatment strategies are available. (1) DCB combined with provisional DES implantation 1-2 mm distally to the lesion ostium whenever this was required (DCB+pDES strategy). (2) DES implantation 1-2 mm distally to the lesion ostium followed by DCB (DES+DCB strategy).
Procedure: Drug-coated balloon combined with provisional drug-eluting stent implantation
(1) DCB combined with provisional DES implantation 1-2 mm distally to the ostium lesion whenever this was required (DCB+pDES strategy). (2) DES implantation 1-2 mm distally to the ostium lesions followed by DCB treatment (DES+DCB strategy).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
late lumen loss
Time Frame: 9 months follow-up
post-procedural minimum lumen diameter minus follow-up minimum lumen diameter.
9 months follow-up
major adverse cardiovascular events
Time Frame: 1 year
include cardiac death, non-fatal myocardial infarction, and target lesion revascularization.
1 year

Collaborators and Investigators

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

Sponsor

Xuzhou Third People's Hospital

Investigators

  • Study Chair: Yaojun Zhang, Dr, 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 (Estimated)

April 22, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

December 3, 2023

First Submitted That Met QC Criteria

December 3, 2023

First Posted (Actual)

December 12, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-02-022-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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