A Multicenter, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of Dissolve™ Compared to SeQuent® Please in Treatment of Coronary In-stent Restenosis in Chinese Population
Sponsor study identifier
interventional
260
1 country
15
Study Start
February 22, 2018
Actual (reported)Primary Completion
January 9, 2020
Actual (reported)Study Completion
April 24, 2024
Actual (reported)The purpose of this study is to evaluate the efficacy and safety of treatment of coronary in-stent restenosis by Paclitaxel-eluting balloon catheter Dissolve™ versus SeQuent®Please, and the reference diameter of coronary artery stenosis is 2.5mm-4.0mm and the length ≤ 26mm.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 24, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 5, 2017
Actual (reported)December 14, 2017
Actual (reported)February 22, 2018
Actual (reported)January 9, 2020
Actual (reported)April 24, 2024
Actual (reported)In-segment Late Lumen Loss
In-segment late lumen loss is defined as the change in minimal lumen diameter (MLD) within the margins of the device and 5 mm proximal and 5 mm distal to the device from post-procedure to 9 months by angiography.
From the end of procedure to 9 months after the procedure
Device success rate of the interventional therapy
From the start of index procedure to end of index procedure
Lesion success rate of the interventional therapy
From the start of index procedure to end of index procedure
Clinical success rate of the interventional therapy
7 days after the procedure
Rate of restenosis in the target lesions
9 months after the procedure
TLR rate
9 months after the procedure
Dissolve™ are to be used in the trial
SeQuent®Please are to be used in the trial
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Beijing Hospital
Beijing, China
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University People's Hospital, Capital Medical University
Beijing, China
Xiangya Hospital of Central South University
Changsha, China
Liu S, Zhou Y, Shen Z, Chen H, Qiu C, Fu G, Li H, Yu Z, Zeng Q, Li Z, Li W, Qiao S; Dissolve ISR Investigators. A Randomized Comparison of 2 Different Drug-Coated Balloons for In-Stent Restenosis. JACC Cardiovasc Interv. 2023 Apr 10;16(7):759-767. doi: 10.1016/j.jcin.2022.12.018.
Shubin Qiao
Chinese Academy of Medical Sciences, Fuwai Hospital
260 participants (actual enrollment reported by the registry).
First Submitted
December 5, 2017
First Posted
December 14, 2017
Study Start
February 22, 2018
Actual (reported)Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System
Contact the study team to confirm eligibility.
West China Hospital, Sichuan University
Chengdu, China
The First Affiliated Hospital of Dalian Medical University
Dalian, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, China
General Hospital of Daqing Oil Field
Daqing, China
Sir Run Run Shaw Hospital, Zhejiang University School of medicine
Hangzhou, China
The First Affiliated Hospital of Zhengzhou University
Hangzhou, China
Union Hospital, Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
General Hospital of Ningxia Medical University
Yinchuan, China
Primary Completion
January 9, 2020
Actual (reported)Study Completion
April 24, 2024
Actual (reported)Last Updated
February 20, 2025
Record last verified: 2025-02
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Source: ClinicalTrials.gov.
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