Safety and Efficacy of DCB Therapy for de Novo Lesions Under the Guidance of QFR in CHD Patients (UNIQUE-DCB-I Study )

November 15, 2023 updated by: Nanjing First Hospital, Nanjing Medical University

Safety and Efficacy of Drug Coated Balloon Therapy for de Novo Lesions in Patients With Coronary Heart Disease Under the Guidance of QFR (UNIQUE-DCB-I Study )

Since Gruntzig successfully performed percutaneous coronary balloon angioplasty in 1977, percutaneous coronary intervention has developed rapidly. From bare metal stents to drug-eluting stents (DES), the symptoms and prognosis of patients with coronary heart disease (CHD) have been greatly improved. Although DES has reduced the probability of in-stent restenosis (ISR) and thrombosis compared with BMS since its clinical application, it can not completely solve this problem. Even if the new generation of DES requires revascularization, the incidence of ISR is still as high as 5%-10%. DES treatment is associated with delayed endothelial healing, late acquired poor stent adherence and new atherosclerosis, which lead to late ISR and thrombosis. In addition, DES is still not ideal for the treatment of small vessel disease, diffuse long lesion and bifurcation lesion. Therefore, drug coated balloon (DCB) has attracted people's attention. Balloon-loaded antiproliferative drugs can fully release the drugs to the vascular wall during balloon dilation, which can inhibit the restenosis process from the beginning of injury, and show good efficacy and safety in some specific lesions. Many clinical studies have shown that DCB has good efficacy and safety in some specific lesions (ISR, small vessel disease, bifurcation disease, in situ lesion). Especially in the treatment of ISR, researchers believe that its efficacy is not inferior to DES, and it has the advantage of non-metal residues.

Quantitative flow ratio (QFR) is the second generation FFR detection method based on angiographic images. The diagnostic accuracy of QFR 0.80 for myocardial ischemic stenosis was 92.7%. Compared with QCA, the positive predictive value and negative predictive value of QFR were also significantly better than those of QCA. The latest FAVOR II results also confirm that QFR is more sensitive and specific in diagnosing myocardial ischemia caused by coronary artery stenosis than QCA, and confirm the feasibility of using QFR online in catheter lab to evaluate the functional significance of coronary artery critical lesions. However, there is no report on the treatment of de novo lesions in patients with coronary heart disease by DCB under the guidance of QFR. The aim of this study was to evaluate the safety and efficacy of drug balloon therapy for de novo lesions in patients with CHD under the guidance of QFR compared with DES implantation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The current study is designed as a multicenter, randomized and prospective study aiming to evaluate the safety and efficacy of drug balloon therapy for de novo lesions in patients with CHD under the guidance of QFR compared with DES implantation. Based on previous study, the incidence rate of target lesion failure is 5%-10% in patients with CHD undergoing DES implantation. And in the investigators study the expected incidence rate of target lesion failure is up to 5.0 % in patients with CHD after treatment with DCB. Moreover, the investigators estimated 10% loss follow-up of these patients in each arm. As a result, a total of 220 patients with CHD were required, and with 110 patients per group as a ratio of 1:1 randomization.

Study Type

Interventional

Enrollment (Estimated)

220

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
      • Nanjing, Jiangsu, China, 210006
        • Nanjing First Hospital
        • Principal Investigator:
          • Fei Ye, MD
        • Contact:
        • 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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

●Meet the diagnostic criteria for stable angina pectoris, unstable angina pectoris and acute myocardial infarction and QFR<0.8 of target lesion

Exclusion Criteria:

  • QFR less than 0.8, dissection above type B and thrombosis formation after pre-dilation of coronary artery lesions
  • Severe congestive heart failure [LVEF <30% or NYHA( New York Heart Association) III/IV)]
  • Severe valvular heart disease
  • Life expectancy no more than 1 year or factors causing difficulties in clinical follow up
  • Intolerance to aspirin and/or clopidogrel
  • Known intolerance or allergy to heparin, contrast agents, paclitaxel, iopromide, rapamycin, polylactic acid-glycolic acid copolymer, Co-Cr alloy or platinum-chromium alloy
  • Leukopenia or thrombopenia
  • A history of peptic ulcer or GI bleeding in the previously
  • Stroke within 6 months prior to the operation
  • A history of severe hepatic or renal failure

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: drug coated balloon
A total of 110 patients are assigned to drug coated balloon treated group after randomization schedule.
Device: drug coated balloon
Balloon/vessel diameter ratio 0.8-1.0, 8-12 ATM (atmosphere), lasting for >30 seconds
No Intervention: drug eluted stent implantation
A total of 110 patients are assigned to drug eluted stent treated group after randomization schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence rate of late lumen loss after percutaneous coronary intervention in patients with CHD
Time Frame: Follow-up coronary angiography at 12 months after the procedure
The incidence rate of late lumen loss between DCB treated group and DES treated group evaluated by quantitative coronary analysis in patients with CHD
Follow-up coronary angiography at 12 months after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence rate of device-related ischemic events
Time Frame: Clinical follow up at 30 days, 6, 9 and 12 months after the procedure
The incidence rate of device-related ischemic events including cardiovascular death, target vessel related myocardial infarction and ischemia-driven revascularization between DCB treated group and DES treated group
Clinical follow up at 30 days, 6, 9 and 12 months after the procedure
The incidence rate of patient-related ischemic events
Time Frame: Clinical follow up at 30 days, 6, 9 and 12 months after the operation
The incidence rate of patient-related ischemic events including all myocardial infarction , any revascularization and all-cause death between DCB treated group and DES treated group
Clinical follow up at 30 days, 6, 9 and 12 months after the operation

Collaborators and Investigators

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

Sponsor

Nanjing First Hospital, Nanjing Medical University

Investigators

  • Principal Investigator: Fei Ye, MD, Nanjing First Hospital, Nanjing Medical University

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)

March 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 23, 2019

First Submitted That Met QC Criteria

September 24, 2019

First Posted (Actual)

September 26, 2019

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY201909

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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