A Multicenter, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of Dissolve™ Compared to Resolute™ Integrity in Treatment of Coronary Small Vessel Disease in Chinese Population
Sponsor study identifier
interventional
277
1 country
15
Study Start
June 20, 2018
Actual (reported)Primary Completion
January 10, 2020
Actual (reported)Study Completion
April 15, 2024
Actual (reported)The purpose of this study is to evaluate the efficacy and safety in the treatment of Coronary Small Vessel Disease by drug coated balloon (DCB) Dissolve™ versus drug eluting stent (DES) Resolute™ Integrity.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 15, 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 8, 2017
Actual (reported)December 18, 2017
Actual (reported)June 20, 2018
Actual (reported)January 10, 2020
Actual (reported)April 15, 2024
Actual (reported)In-segment percent diameter stenosis of the target lesion at 9 months after procedure
9 months after the procedure
Device success rate of the interventional therapy
From the start of index procedure to the end of index procedure, Day 0
Lesion success rate of the interventional therapy
From the start of index procedure to the end of index procedure, Day 0
Clinical success rate of the interventional therapy
7 days after the procedure
In-device percent diameter stenosis of the target lesion
9 months after the procedure
In-device minimal lumen diameter (MLD)
9 months after the procedure
Cohort B is single arm.
Dissolve™ are to be used in the trial
Resolute™ Integrity are to be used in the trial
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 SVD investigators. Comparison of Drug-Coated Balloon and Drug-Eluting Stent for the Treatment of Small Vessel Disease (from the Dissolve SVD Randomized Trial). Am J Cardiol. 2024 Jan 15;211:29-39. doi: 10.1016/j.amjcard.2023.05.057. Epub 2023 Nov 22.
Shubin Qiao
Chinese Academy of Medical Sciences, Fuwai Hospital
277 participants (actual enrollment reported by the registry).
First Submitted
December 8, 2017
First Posted
December 18, 2017
Study Start
June 20, 2018
Actual (reported)Dissolve™ 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.
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
Union Hospital, Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
General Hospital of Ningxia Medical University
Yinchuan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Primary Completion
January 10, 2020
Actual (reported)Study Completion
April 15, 2024
Actual (reported)Last Updated
February 20, 2025
Record last verified: 2025-02
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Source: ClinicalTrials.gov.
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