Coronary Intravascular Lithotripsy System in Patients With Coronary Artery Calcification (VIGOUR)
NCT05818098 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 189
Last updated 2026-08-10
Summary
This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary intravascular lithotripsy system for the treatment of patients with coronary calcification.
Conditions
- Coronary Artery Calcification
Interventions
- DEVICE
-
Intravascular Lithotripsy System of Shanghai MicroPort Rhythm
The Intravascular Lithotripsy System is a single-use, sterile, disposable balloon angioplasty catheter that contains a series of unfocused, electrohydraulic lithotripsy emitters, which convert electrical energy into transient acoustic circumferential pressure pulses that disrupt both superficial and deep calcium within vascular plaque.
Sponsors & Collaborators
-
The Second Affiliated Hospital of Harbin Medical University
collaborator OTHER -
Huai'an First People's Hospital
collaborator OTHER -
People's Hospital of Xinjiang Uygur Autonomous Region
collaborator OTHER -
First Affiliated Hospital Xi'an Jiaotong University
collaborator OTHER -
West China Hospital
collaborator OTHER -
Wuhan Central Hospital
collaborator OTHER -
First Hospital of China Medical University
collaborator OTHER -
Shanxi Bethune Hospital
collaborator OTHER -
Hebei Provincial People's Hospital
collaborator OTHER -
The Second Hospital of Hebei Medical University
collaborator OTHER -
Shanxi Cardiovascular Hospital
collaborator OTHER -
Shengjing Hospital
collaborator OTHER -
Three Gorges Hospital of Chongqing University
collaborator OTHER -
The First Hospital of Jilin University
collaborator OTHER -
Xiamen Cardiovascular Hospital, Xiamen University
collaborator OTHER -
The People's Hospital of Liaoning Province
collaborator OTHER -
Shanghai East Hospital
collaborator OTHER -
Linfen No.4 People's Hospital
collaborator OTHER -
Shanghai MicroPort Rhythm MedTech Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Bo Yu, M.D. · The Second Affiliated Hospital of Harbin Medical University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-29
- Primary Completion
- 2023-09-15
- Completion
- 2023-09-15
Countries
- China
Study Locations
More Related Trials
-
Trial for MicroPort's Firesorb BVS: FUTURE-III
NCT03660202 ·Status: UNKNOWN ·Phase: NA
-
A U.S Post Approval Study Evaluating the SYNERGY XLV (MEGATRON) Stent System
NCT04807439 ·Status: COMPLETED
-
Safety and Effectiveness of GENOSS® DES in Patients With Multivessel Coronary Artery Disease
NCT06168305 ·Status: ENROLLING_BY_INVITATION
-
The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study
NCT05489588 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
NCT03752866 ·Status: COMPLETED ·Phase: NA
-
Investigation of the NVT ALLEGRA Plus THV System in Patients With Severe Aortic Stenosis or Failed Surgical Aortic Bioprosthesis
NCT05804903 ·Status: SUSPENDED ·Phase: NA
-
Effectiveness and Safety of a Novel Intravascular Lithotripsy System in Severely Calcified Coronary Lesions(COCALP)
NCT06787547 ·Status: COMPLETED ·Phase: NA
-
The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study
NCT05409976 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
NCT03517436 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Evaluation of New Specifications (2.25mm) of FirehawkTM in the Treatment of Coronary Heart Disease ( Firehawk_2.25 )
NCT02688868 ·Status: COMPLETED ·Phase: NA
-
Cynergy: the CYPHER-NEVO Registry
NCT01106378 ·Status: TERMINATED
-
Firebird2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent Registry Trial
NCT00868829 ·Status: UNKNOWN ·Phase: NA
-
The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease
NCT05811364 ·Status: RECRUITING ·Phase: NA
-
Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)
NCT06385379 ·Status: RECRUITING ·Phase: NA
-
VitaFlowTM II Transcatheter Aortic Valve System Study
NCT03575039 ·Status: UNKNOWN ·Phase: NA
-
Prospective, Non-Randomised Clinical Trial to Investigate the BeGraft Aortic Stent Graft System and the BeGraft Peripheral Stent Graft System Treating Aortic-iliac Occlusive Disease
NCT05805111 ·Status: RECRUITING
-
VIVO Clinical Study
NCT01970007 ·Status: COMPLETED ·Phase: NA
-
Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting
NCT04900844 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
SiREX-Stent for the Treatment of SymptOmatic Lateral VEnous Sinus Stenosis
NCT06726928 ·Status: RECRUITING ·Phase: NA
-
Evaluation of the GORE® C3 Delivery System Module
NCT01398332 ·Status: COMPLETED
-
Evaluate the Safety and Efficacy of Intracoronary Lithotripsy Balloon Catheter and Intracoronary Lithotripsy Apparatus
NCT05649488 ·Status: UNKNOWN ·Phase: NA
-
The Efficacy and Safety of Intracranial Stent (Tonbridge) in Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis
NCT05757505 ·Status: RECRUITING ·Phase: NA
-
Innoventric Trillium™ Stent Graft First-in-Human (FIH) Study
NCT04289870 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
A Study of Implantation of CRENEOUS ENTERPRISE 2 Intracranial Stent in Participants With Severe Symptomatic Intracranial Atherosclerotic Stenosis
NCT05316311 ·Status: COMPLETED ·Phase: NA
-
Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm PTCA Dilatation Catheter
NCT01635881 ·Status: COMPLETED ·Phase: PHASE3