Comparing Intravascular Lithotripsy and Conventional Therapy for Calcified Coronary Arteries

Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions: an Investigator-initiated, Open-label, Multicentre, Randomised, Superiority Trial

This study is testing if a new treatment using intravascular lithotripsy can help people with severely calcified coronary arteries get better results from their stents compared to standard treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xijing Hospital (Academic / other)
• Locations: 1 site (Xi'an, Shannxi)
• Trial ID: NCT06238518 on ClinicalTrials.gov

What this trial studies

This pilot randomized trial investigates the effectiveness of intravascular lithotripsy (IVL) combined with conventional therapy for treating severely calcified coronary artery lesions. The study aims to determine if this novel approach leads to better stent expansion and fewer long-term adverse events compared to conventional methods alone. Patients with acute or chronic coronary artery syndrome who require percutaneous coronary intervention (PCI) will be enrolled based on specific angiographic criteria for severely calcified lesions. The primary endpoints include assessing stent expansion using optical coherence tomography (OCT) and monitoring safety outcomes.

Who should consider this trial

Good fit: Ideal candidates are patients with acute or chronic coronary artery syndrome requiring PCI and having severely calcified lesions.

Not a fit: Patients under 18 years of age or those with lesions not meeting the specified criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve stent expansion and reduce complications for patients with severely calcified coronary lesions.

How similar studies have performed: Preliminary outcomes from other studies using intravascular lithotripsy have shown promise, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

General Inclusion Criteria:

1. Patients with acute or chronic coronary artery syndrome indicated for PCI with stenting.
2. Able to understand and provide informed consent and comply with all study procedures

Angiographic Inclusion Criteria:

1. Native and de novo coronary artery disease
2. Lesion navigable by a 0.014" guidewire.
3. Target lesion is severely calcified, meeting one of the following criteria:

   * Presence of calcium ≥ 270°, lengths ≥ 5mm, and thickness ≥ 0.5mm at one cross-section as assessed by OCT
   * If the OCT catheter is unable to pass through the target lesion after dilatation due to calcification or tortuosity, and the target lesion is severely calcified on both sides of the arterial wall during angiography, with the length of the calcification \>15 mm, the lesion will be recognized as a severely calcified lesion, meeting the criteria for enrollment

Exclusion Criteria:

General Exclusion Criteria:

1. Patients under 18 years of age.
2. Incapable of providing informed consent.
3. Female patients who are pregnant or nursing (a pregnancy test must be conducted within 7 days before the index procedure for women of childbearing potential, as per local practice).
4. Concurrent medical conditions with a life expectancy of less than 1 year.
5. Hemodynamic instability.
6. Known contraindications to medications such as Heparin, anticoagulation, antiplatelet drugs, or contrast.
7. Active bleeding.
8. New-onset stroke or transient ischemic attack (TIA) within 90 days prior to enrollment.
9. Severe renal dysfunction (eGFR ≤ 30 ml/min).
10. Patients scheduled to undergo cardiac intervention or cardiac surgery within 30 days of the index procedure.
11. Recent ST-segment elevation myocardial infarction (STEMI) within 7 days or recent cardiogenic shock.
12. Lesions located in surgical conduits.

Angiographic Exclusion Criteria:

1. Target vessel exhibiting C-F type dissection.
2. Thrombosis observed by angiography or OCT.
3. Presence of an aneurysm within 10 mm of the target lesion.
4. Left main ostial lesion

Where this trial is running

Xi'an, Shannxi

• Ling Tao — Xi'an, Shannxi, China (Recruiting)

Study contacts

• Study coordinator: Chao Gao,, M.D, Ph.D

Conditions Severely Calcified Coronary Stenoses; De Novo Stenosis; Intravascular Lithotripsy; percutaneous coronary intervention