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Coronary Artery DiseaseNCT05433376

SOLSTICE Trial in China

A study testing Shockwave Coronary Intravascular Lithotripsy (IVL) System C2 in people with Coronary Artery Disease and Calcifications Vascular, run by Genesis Medtech Corporation at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a small sample size clinical trial in Chinese population to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System to treat de novo, calcified, stenotic, coronary lesions prior to stenting. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Shockwave Coronary Intravascular Lithotripsy (IVL) System C2
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
3 sitesChina
Study dates
15 Apr 2021to 26 Nov 2022
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General
  • Subject ≥18 and ≤80 years of age，male or female.
  • Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
  • Subject or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
  • Angiographic
  • Evidence of calcification at the lesion site by, a) angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion, OR by b) OCT, with presence of ≥270 degrees of calcium on at least 1 cross section
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  • The lesion length must not exceed 40 mm
  • The target vessel reference diameter must be ≥2.5 mm and ≤4.0 mm
  • de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches), per investigator's assessment with:
  • Stenosis of ≥70% and <100% or
  • Stenosis ≥50% and <70% (visually assessed) that is deemed qualified for PCI by investigator
  • The target vessel must have TIMI flow 3 at baseline (visually assessed; may be assessed after pre-dilatation)
  • Ability to pass a 0.014" guide wire across the lesion

Who cannot join

  • General
  • Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
  • Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure
  • Subjects with cardiogenic shock or acute left heart failure; New York Heart Association (NYHA) class III or IV heart failure; left ventricular ejection fraction (LVEF) ≤ 35% within 6 months prior to the procedure (Note: if multiple LVEF assessments were performed, the measurement closest to index procedure will be chosen; it can be assessed in the procedure);
  • History of a stroke or transient ischemic attack (TIA) within 6 months, or any prior intracranial hemorrhage or permanent neurologic deficit
  • Uncontrolled diabetes defined as a HbA1c ≥10%
Show all 38Show fewer
  • Non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days prior to the index procedure
  • Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
  • Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
  • Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
  • Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment); Or plans to become pregnant within 13 months after the study procedure;
  • Unable to tolerate dual antiplatelet therapy (i.e., aspirin, and either clopidogrel, prasugrel, or ticagrelor) for at least 6 months (for patients not on oral anticoagulation)
  • Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated
  • Renal failure with serum creatinine >2.5 mg/dL or chronic dialysis
  • Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months
  • Untreated pre-procedural hemoglobin <10 g/dL or intention to refuse blood transfusions if one should become necessary
  • Coagulopathy, including but not limited to platelet count <100,000 or International Normalized ratio (INR) > 1.7 (INR is only required in subjects who have taken warfarin within 2 weeks of enrollment)
  • Subject has a hypercoagulable disorder such as polycythemia vera, platelet count >750,000 or other disorders
  • Biomarkers [troponin or CK-MB] greater than the upper laboratory normal limit within 72 hours prior to index procedure (note: if both biomarkers are available, both must be normal)
  • Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
  • Subjects with a life expectancy of less than 1 year
  • Planned use of atherectomy, laser or scoring or cutting balloon, or any investigational device other than lithotripsy Angiographic
  • Previous stent within the target vessel implanted within the last year
  • Previous stent within 10 mm of the target lesion regardless of the timing of its implantation
  • Angiographic evidence of a dissection (≥ grade C) in the target vessel at baseline or after guidewire passage
  • Lesions in non-target vessels requiring PCI as below should be excluded:
  • 24 hours to 30 days prior to the study procedure if the procedure was unsuccessful or complicated; or
  • In 24 hours prior to the study procedure
  • >30 days after the study procedure
  • Non-target lesion is including left main lesion with diameter stenosis ≥30%
  • Target vessel is too tortuous to deliver a stent assessed by investigators.
  • Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel
  • Evidence of aneurysm in target vessel within 10 mm of the target lesion
  • Target lesion is an ostial location (LAD, LCX, or RCA, within 5 mm of ostium) or an unprotected left main lesion.
  • Target lesion is a bifurcation with ostial diameter stenosis ≥30%
  • Second lesion with >50% stenosis in the same target vessel as the target lesion including its side branches
  • Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
  • Other situations not suitable for enrollment assessed by investigators.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Beijing Anzhen Hospital,Capital Medical University

    Beijing

  • Beijing Friendship Hospital,Capital Medical University

    Beijing

  • Chinese Peoples Liberation Army General Hospital

    Beijing

Other trials in China

About this study

Official title: Clinical Trial of the ShOckwave Coronary Intravascular Lithotripsy (IVL) System Used to Treat CalcIfied Coronary ArtEries (SOLSTICE)

This is a small sample size clinical trial in Chinese population to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System to treat de novo, calcified, stenotic, coronary lesions prior to stenting.

Being tested
Shockwave Coronary Intravascular Lithotripsy (IVL) System C2
Medical subject headings
Coronary Artery Disease, Vascular Calcification

What participants receive

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

  • Shockwave Coronary Intravascular Lithotripsy (IVL) System C2Device

    lithotripsy-enabled, low-pressure dilatation balloon to modify severely calcified lesions

Study groups in NCT05433376
Study groupRoleWhat they receive
IVL groupExperimentalNot described
Receives: Device: Shockwave Coronary Intravascular Lithotripsy (IVL) System C2

What is being measured

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

  1. Procedural Success

    defined as stent delivery with a residual stenosis <50% (core laboratory assessed, angiographically) and without in-hospital MACE

    Measured: in 24 hours post-procedure or prior to discharge, whichever comes first

  2. Freedom from major adverse cardiac events (MACE) within 30 days of the index procedure.

    MACE is defined as:

    • Cardiac death; or
    • Myocardial Infarction (MI) defined as CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave at discharge (periprocedural MI) and using the Fourth Universal Definition of Myocardial Infarction beyond discharge (spontaneous MI); or
    • Target Vessel Revascularization (TVR) defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure

    Measured: 30 days post index procedure

Timeline

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

  1. First posted27 Jun 2022
  2. Study start15 Apr 2021
  3. Primary completion25 Nov 2021
  4. Study completion26 Nov 2022 (estimated)

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05433376
Sponsor's protocol ID
GM-PI-CIP001
Status last verified
Jun 2022
First submitted
15 Jun 2022
Last updated
27 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Shockwave Coronary Intravascular Lithotripsy (IVL) System C2 in people with Coronary Artery Disease and Calcifications Vascular, run by Genesis Medtech Corporation at 3 sites 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 13 inclusion and 38 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: status not confirmed, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Results are not available in the source record.

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?

Procedural Success (time frame: in 24 hours post-procedure or prior to discharge, whichever comes first). The study lists 2 primary outcomes in all. 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 NCT05433376.

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 27 Jun 2022; AzTrials last refreshed its copy on 27 Oct 2026.

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