AzTrials
AzTrials

Coronary Artery CalcificationNCT05818098

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

A study testing Intravascular Lithotripsy System of Shanghai MicroPort Rhythm in people with Coronary Artery Calcification, run by Shanghai MicroPort Rhythm MedTech Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Coronary Artery Calcification
What is being tested?
Intravascular Lithotripsy System of Shanghai MicroPort Rhythm
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
189 participants
Where
1 siteChina
Study dates
29 Mar 2023to 15 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical Inclusion Criteria:
  • 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.
Show all 20Show fewer
  • 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:
  • 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
  • Presence of calcium of ≥270°at one cross-section via IVUS or OCT
  • 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.

Who cannot join

  • General Exclusion Criteria:
  • 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.
Show all 35Show fewer
  • 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.
  • Subjects who have been treated with intracoronary brachytherapy at any time previously.
  • Subjects who are allergic to investigational stent system or concomitant drugs required in the protocol (such as everolimus, sirolimus, or structure-related compounds; fluorine-containing polymers; antiplatelet agents such as aspirin, ticagrelor, or thienopyridines; contrast agent; narcotics).
  • Subjects with other serious medical conditions (such as cancer) may shorten their life expectancy to less than 12 months.
  • Subjects who plan to undergo a procedure that may lead to non-conformity with the protocol or confusion in data interpretation.
  • Subjects who are participating in another investigational drug or device clinical trial in which the primary endpoint is still not reached, or intend to participate in another investigational drug or device clinical trial within 6 months after baseline procedure.
  • Pregnant or breast-feeding subjects (women who may become pregnant must receive a pregnancy test within seven days prior to the baseline procedure).
  • Subjects who are found to have poor compliance and unable to complete the trial as required as judged by the investigators.
  • Angiography Exclusion Criteria:
  • Subjects with target lesions meet the following criteria:
  • Target lesions located within or involving 5 mm of the ostium of the left and right main coronary arteries (LAD/LCX/RCA);
  • Target lesions that involve bifurcation lesions (bifurcation lesion ostial diameter stenosis greater than 30%);
  • Entering through a great saphenous vein graft or an artery graft;
  • Target lesions with thrombosis or suspected thrombosis;
  • Target vessel with C-F type dissection according to NHLBI classification following pre-procedure angiography or guidewire crossing;
  • In-stent restenosis involved in target lesions.
  • 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).

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affliated Hospital Ha'erbin Medical University

    Harbin, Heilongjiang

Other trials in China

About this study

Official title: A Prospective, Multicenter Clinical Trial in Evaluating the Safety and Efficacy of the Intravascular Lithotripsy System in Patients With Coronary Artery Calcification

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.

Read the detailed description

This trial is a prospective and multicenter clinical trial. 189 subjects are expected to be recruited in 20 research centers in China.

  1. All subjects with coronary calcified lesions participating in this clinical study must have only one lesion length of no more than 40 mm and located in an coronary artery with a diameter of ≥ 2.00 mm but ≤ 4.00 mm.
  2. All subjects receive clinical follow-up during hospitalization, 30 days and 6 months after surgery.
Being tested
Intravascular Lithotripsy System of Shanghai MicroPort Rhythm
Keywords
calcification, coronary artery
Medical subject headings
Calcinosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravascular Lithotripsy System of Shanghai MicroPort RhythmDevice

    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.

Study groups in NCT05818098
Study groupRoleWhat they receive
Intravascular Lithotripsy SystemExperimentalSubjects in experimental group will be treated with the Intravascular Lithotripsy System manufactured by Shanghai Microport Rhythm Co. Ltd.
Receives: Device: Intravascular Lithotripsy System of Shanghai MicroPort Rhythm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Procedure success rate

    Procedure success is defined as stent implantation with residual diameter stenosis ≤30% and no major adverse cardiac events (MACE) during hospitalization (up to 7 days post-procedure). MACE is defined as the composite of cardiac death, myocardial infarction, and target vessel revascularization.

    Measured: During hospitalization (up to 7 days after procedure)

Secondary outcomes (4)

  1. Device success rate

    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.

    Measured: Baseline procedure

  2. Angiographic success rate

    Angiographic success is defined as stent delivery with ≤30% residual stenosis and without serious angiographic complications.

    Measured: Baseline procedure

  3. 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.)

    Measured: within 30 days of baseline procedure

  4. 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.

    Measured: Baseline procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2023
  2. Study start29 Mar 2023
  3. Primary completion15 Sep 2023
  4. Study completion15 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05818098
Sponsor's protocol ID
AMD-D-002
Status last verified
Aug 2026
First submitted
5 Apr 2023
Last updated
10 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41077810

Questions about this trial

What is this clinical trial studying?

A study testing Intravascular Lithotripsy System of Shanghai MicroPort Rhythm in people with Coronary Artery Calcification, run by Shanghai MicroPort Rhythm MedTech Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedure success rate (time frame: During hospitalization (up to 7 days after procedure)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05818098, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in