Safety and Efficacy of DCB Therapy for ISR Under the Guidance of QFR (UNIQUE-DCB-II Study )

May 27, 2025 updated by: Nanjing First Hospital, Nanjing Medical University

Safety and Efficacy of Drug Coated Balloon Therapy for Coronary In-stent Restenosis in Patients With Coronary Heart Disease Under the Guidance of QFR (UNIQUE-DCB-II Study)

In 1970, the first percutaneous balloon coronary angioplasty opened a new chapter of interventional therapy. However, the incidence of intracoronary restenosis was about 30%. Subsequently, bare metal stents and drug-eluting stents (DES) reduced the incidence of in-stent restenosis (ISR) to 5%-10% and it was still a bottleneck treated by percutaneous coronary intervention (PCI). Currently, ISR is mainly treated by balloon angioplasty, stent implantation and coronary artery bypass grafting.

In 2014, the guidelines of the European Society of Cardiology recommended that drug balloon therapy (DCB) and new generation DES should be the preferred strategies for ISR treatment. Compared with DES, DCB treatment can avoid the inflammation of intima caused by multi-layer stent strut, and reduce the risk of intimal hyperplasia and thrombosis in stent. However, DCB lacks sustained radial support. Even if the residual stenosis is less than 30% after sufficient pre-dilation, the elastic retraction of the intima still exists. In addition, the antiproliferative effect of paclitaxel is significantly worse than that of sirolimus and its derivatives, and there is a lack of long-term sustained release of anti-proliferative drugs. Compared with DCB, DES can obtain long-term stable radial support and long-term anti-proliferation effect, but stent struts exposed in the vascular lumen are at risk of stent thrombosis. The new generation of DES improves the design of stent platform, improves the polymer coating, and applies new anti-proliferative drugs. It effectively reduces the inflammation of vascular wall, speeds up the process of vascular re-endothelialization, promotes early vascular repair, and significantly reduces the incidence of stent thrombosis. Recent BIOLUXRCT, RESTORE and DARE studies provide more powerful evidence for the treatment of ISR by new generation DES.

Quantitative flow ratio (QFR) is the second generation FFR detectional method based on coronary contrast image. The latest FAVOR II results also confirm that QFR is more sensitive and specific than quantitative coronary analysis (QCA) in the diagnosis of myocardial ischemia caused by coronary artery stenosis. However, there is no report of ISR treated with DCB under the guidance of QFR. The aim of this study was to evaluate the safety and efficacy of DCB in the treatment of in-stent restenosis in patients with coronary heart disease (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 ISR in patients with CHD under the guidance of QFR compared with DES implantation. Based on previous study reported, the incidence rate of target lesion failure is about 3% in patients with ISR undergoing DES implantation. And the design of non-inferiority study was performed in our study. Moreover, the investigators estimated 10% loss follow-up of these patients in each arm. As a result, a total of 220 patients with ISR 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
        • 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 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

● Meet the diagnostic criteria for patients with coronary in-stent restenosis and QFR<0.8 of target lesion in the coronary stent

Exclusion Criteria:

  • QFR less than 0.8, dissection above type B and thrombosis formation after pre-dilation of ISR
  • 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 with ISR 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.
Other: drug eluted stent implantation
A total of 110 patients with ISR are assigned to drug eluted stent treated group after randomization schedule.
Device: drug eluted stent
with regular techniques

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 ISR
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 ISR
Follow-up coronary angiography at 12 months after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)

January 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

October 7, 2019

First Submitted That Met QC Criteria

October 7, 2019

First Posted (Actual)

October 9, 2019

Study Record Updates

Last Update Posted (Actual)

May 31, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY201910

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

product manufactured in and exported from the U.S.

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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