Coronary Intravascular Lithotripsy System in Patients With Coronary Artery Calcification (VIGOUR)

NCT05818098 | Unknown

• 1 other identifier: AMD-D-002
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

calcification; coronary artery

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• Device success

  Baseline procedure

• Angiographic success

  Baseline procedure

• MACE freedom rate at 30 days after the index procedure

  within 30 days of baseline procedure

• Procedure-related serious complications

  Baseline procedure

Study Arms (1)

Intravascular Lithotripsy System

EXPERIMENTAL

Subjects in experimental group will be treated with the Intravascular Lithotripsy System manufactured by Shanghai Microport Rhythm Co. Ltd.

Device: Intravascular Lithotripsy System of Shanghai MicroPort Rhythm

Interventions

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.

Intravascular Lithotripsy System

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged between 18 and 85.
• Subjects who can undergo percutaneous coronary intervention (PCI).
• Subjects with asymptomatic evidence of ischemia, stable or unstable angina pectoris, or old myocardial infarction.
• Left Ventricular Ejection Fraction (LVEF) ≥30% as measured by echocardiography for subjects within 6 months before enrollment. (In case of multiple LVEF results, the data closest to the baseline procedure was taken.)
• Subjects who are able to understand the purpose of the trial, participate voluntarily or by proxy and indicate by signing the informed consent form that they recognize the risks and benefits described in the informed consent document and are willing to undergo clinical follow-up.
• 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:
• Exercise stress test positive
• Fractional Flow Reserve (FFR) ≤ 0.8 or iFR \< 0.9
• Minimum lumen area (MLA) ≤ 4.0 mm2 by IVUS or OCT
• The target lesion length must be less than 40 mm (visually measured).
• The target lesion must meet one of the following :
• During angiography, clear hyperdense opacities can be observed on both sides of the arterial wall when the heart pulsates and does not pulsate

You may not qualify if:

• Subjects who present with AMI recently (within 7 days)
• Subjects who have hemodynamic instability or a severe reduction in activity tolerance (NYHA cardiac function Grade Ⅲ, Ⅳ).
• Subjects who have an intra-cardiac thrombus as shown by echocardiography within 30 days before enrollment.
• Subjects who have already received or are waiting for organ transplantation.
• Subjects who are receiving or scheduled to receive chemotherapy within 30 days before or after the baseline procedure.
• Subjects who have a platelet count \< 60 x 10\^9/L or \> 750 x 10\^9/L or other hemorrhagic diathesis, coagulation dysfunction, blood transfusion resistance.
• Subjects who have severe hepatic dysfunction (transaminases more than 3 times the upper limit of normal).
• Subjects who have chronic renal failure and a serum creatinine level \> 2.5 mg/Dl (or 221µmol/L).
• Subjects who have active peptic ulcer diseases or active gastrointestinal (GI) bleeding within 6 months before enrollment.
• Subjects who are unable to receive dual antiplatelet therapy for at least 6 months due to various reasons.
• Subjects who experience cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past six months, or have permanent neurological defects that may cause nonconformity with the protocol.
• Subjects who plan to undergo rotational atherectomy, cutting balloon, scored balloon, or laser coronary atherectomy during the baseline procedure.
• Subjects who have received stent placement for target vessel (including collateral branches) within 12 months prior to the baseline procedure.
• Subjects who have received any type of PCI treatment for non-target vessels within 24 hours prior to the baseline procedure.
• Subjects who are scheduled to receive a cardiac intervention or cardiac surgery within 30 days of the index procedure.

Sponsors & Collaborators

• Shanghai MicroPort Rhythm MedTech Co., Ltd.: lead

Study Sites (1)

The Second Affliated Hospital Ha'erbin Medical University

Harbin, Heilongjiang, China

RECRUITING

MeSH Terms

Conditions

Calcinosis

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Bo Yu, M.D.

  The Second Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tingting Wu, M.D.

CONTACT

0086-021-38954600; TingTing.Wu2@microport.com

Bo Yu, M.D.

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 18, 2023
• Study Start: March 29, 2023
• Primary Completion: September 1, 2023
• Study Completion: March 1, 2024
• Last Updated: April 18, 2023

Record last verified: 2022-11

Locations

CN (1)