SOLSTICE Trial in China

NCT05433376 | Unknown

• 1 other identifier: GM-PI-CIP001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Coronary Artery Disease; Calcifications Vascular

Outcome Measures

Primary Outcomes (2)

• Procedural Success

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

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

• 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

  30 days post index procedure

Study Arms (1)

IVL group

EXPERIMENTAL

Device: Shockwave Coronary Intravascular Lithotripsy (IVL) System C2

Interventions

Shockwave Coronary Intravascular Lithotripsy (IVL) System C2 DEVICE

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

IVL group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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%
• 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

Sponsors & Collaborators

• Genesis Medtech Corporation: lead

Study Sites (3)

Beijing Anzhen Hospital,Capital Medical University

Beijing, China

Location

Beijing Friendship Hospital,Capital Medical University

Beijing, China

Location

Chinese Peoples Liberation Army General Hospital

Beijing, China

Location

MeSH Terms

Conditions

Coronary Artery Disease; Vascular Calcification

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

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: June 15, 2022
• First Posted: June 27, 2022
• Study Start: April 15, 2021
• Primary Completion: November 25, 2021
• Study Completion: November 26, 2022
• Last Updated: June 27, 2022

Record last verified: 2022-06

Locations

CN (3)