Safety and Efficacy of DCB Therapy for ISR Under the Guidance of QFR (UNIQUE-DCB-II Study )
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|ClinicalTrials.gov Identifier: NCT04119986|
Recruitment Status : Not yet recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Heart Disease||Device: drug coated balloon Device: drug eluted stent||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Estimated Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||December 1, 2023|
|Estimated Study Completion Date :||December 1, 2023|
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.
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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119986
|Contact: Fei Ye, MD||+86 email@example.com|
|Contact: Xiangqi Wu, MD||+86 firstname.lastname@example.org|
|Nanjing First Hospital||Not yet recruiting|
|Nanjing, Jiangsu, China, 210006|
|Contact: Jie Zhou +8613913893984 email@example.com|
|Principal Investigator:||Fei Ye, MD||Nanjing First Hospital, Nanjing Medical University|