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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.
This trial is a prospective and multicenter clinical trial. 189 subjects are expected to be recruited in 20 research centers in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravascular Lithotripsy System | Experimental | Subjects in experimental group will be treated with the Intravascular Lithotripsy System manufactured by Shanghai Microport Rhythm Co. Ltd. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravascular Lithotripsy System of Shanghai MicroPort Rhythm | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure success | Procedure success is defined as the ability of intravascular lithotripsy (IVL) to produce residual diameter stenosis ≤30% after stenting with no evidence of in-hospital MACE (maximum of 7 days) (MACE: defined as the composite of cardiac death, myocardial infarction, and target vessel revascularization) | During hospitalization (up to 7 days after procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| Device success | Device success is defined as delivery of the IVL catheter across the target lesion and delivery of lithotripsy without serious angiographic complications immediately after IVL. | Baseline procedure |
| Angiographic success |
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Inclusion Criteria:
Clinical Inclusion Criteria:
Angiography Inclusion Criteria:
There is only one target lesion that needs to be treated.
The target lesion must be located in a de novo native coronary artery with a reference vessel diameter (RVD) ≥2.00 mm to ≤4.00 mm as visually measured.
The target lesion angiography shows a stenosis rate ranging from ≥70% (visually measured) or ≥50% to <70% with symptoms of ischemia.
Ischemic symptoms were defined as any of the following:
The target lesion length must be less than 40 mm (visually measured).
The target lesion must meet one of the following :
Target lesion TIMI flow 3 prior to the use of the test device (at baseline or after balloon pre-dilatation).
The lesion that 0.014 "guidewire can cross.
Exclusion Criteria:
General Exclusion Criteria:
Angiography Exclusion Criteria:
Subjects with target lesions meet the following criteria:
Subjects with unprotected left main coronary artery diseases (diameter stenosis >30%).
Subjects with other clinically significant lesions at target vessels (diameter stenosis >50%).
The target vessel (including collateral) near the target lesion or within 10 mm (visually) from the distal end of the target lesion has received stent implantation at any time before baseline surgery.
Subjects with lesions that guide wire cannot pass through or retrieve due to various reasons (such as serious distortion at the proximal target vessel).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tingting Wu, M.D. | Contact | 0086-021-38954600 | 50327 | TingTing.Wu2@microport.com |
| Bo Yu, M.D. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bo Yu, M.D. | The Second Affiliated Hospital of Harbin Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affliated Hospital Ha'erbin Medical University | Recruiting | Harbin | Heilongjiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41077810 | Derived | Chen T, Zhao J, He Y, Fang C, Han X, Luan B, Wang Y, Chen M, Yuan Z, Tong Q, Gao Y, Gu G, Li X, Yang Y, Yu H, Ma L, Liu H, Xu M, Zhang D, Yang G, Zhang S, Han J, Zhang M, Jia H, Hou J, Yu B. Safety and Efficacy of Intravascular Lithotripsy System: A Prospective, Multicenter Clinical Trial (The VIGOUR Study). Catheter Cardiovasc Interv. 2025 Dec;106(7):3599-3608. doi: 10.1002/ccd.70248. Epub 2025 Oct 12. |
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| ID | Term |
|---|---|
| D002114 | Calcinosis |
| ID | Term |
|---|---|
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Angiographic success is defined as stent delivery with ≤30% residual stenosis and without serious angiographic complications.
| Baseline procedure |
| MACE freedom rate at 30 days after the index procedure | MACE is defined as a composite of cardiac death, myocardial infarction[MI], and target vessel revascularization [TVR]. (Periprocedural MI is defined as peak post-PCI CK-MB level >3 x the upper limit of normal [ULN], both non-Q wave myocardial infarction or Q-wave myocardial infarction.) | within 30 days of baseline procedure |
| Procedure-related serious complications | Procedure-related serious complications included severe dissection (Type D-F, according to NHLBI classification system), perforation, abrupt closure, and persistent slow flow/no-reflow during the baseline procedure. | Baseline procedure |