A Prospective, Multicenter, Single-arm Study to Evaluate the Safety and Efficacy of Pulsed Sonic Balloon Dilatation Catheter and Pulsed Sonic Generater in the Treatment of Coronary Calcified Lesions
Sponsor study identifier
interventional
170
1 country
14
Study Start
May 6, 2022
Actual (reported)Primary Completion
October 7, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 7, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The prospective, multicenter, single- arm study is designed to verify the safety and efficacy of pulsed sonic balloon dilatation catheter and pulsed sonic generater in the treatment of coronary calcification lesions.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 7, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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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.
May 6, 2022
Actual (reported)May 27, 2022
Actual (reported)June 7, 2022
Actual (reported)October 7, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 7, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Procedural success rate
Procedural success was defined as residual stenosis ≤30% after successful stent delivery without the occurrence of in-hospital adverse cardiac events (include cardiac death, target vessel-related myocardial infarction (TV-MI) and target lesion revascularizition)
immediate post-procedure
Device success rate
immediate post-procedure
Lumen diameter obtained
immediate post sonic balloon treatment, immediate post-procedure
Percentage of diameter stenosis
immediate post sonic balloon treatment, immediate post-procedure
Target Lesion Failure (TLF)
before discharge or 7 days post-procedure, 30 days post-procedure
Patient-related cardiovascular clinical composite endpoint (POCE)
before discharge or 7 days post-procedure, 30 days post-procedure
All subjects will receive treatment from the pulsed sonic balloon dilatation catheter
Deliver Pulsed Sonic Balloon Dilatation Catheter to the target vessel prior to placing a coronary stent or others
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 Univesity
Beijing, Beijing Municipality, China
Beijing Chao-yang Hospital , Capital Medical University
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The Southwest Hospital of Amu
Chongqing, China
The First Affiliated Hospital, Sun Yat-sen University
Yida Tang
Peking University Third Hospital
First Submitted
May 27, 2022
First Posted
June 7, 2022
Study Start
May 6, 2022
Actual (reported)Primary Completion
October 7, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Guangzhou, China
The Second Xiangya Hospital of Central South University
Hunan, China
Xiangya Hospital Central South University
Hunan, China
LinFen Central Hospital
Shanxi, China
The First Affiliated Hospital of Soochow University
Suzhou, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
Xuzhou central hospital
Xuzhou, China
Sir Run Run Shaw Hospital ZheJiang University School of Medicine
Zhejiang, China
Study Completion
January 7, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 7, 2022
Record last verified: 2022-05
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Source: ClinicalTrials.gov.
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