Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions

Last updated: January 25, 2024
Sponsor: Xijing Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Treatment

Conventional lesion preparation strategy

Intravascular Lithotripsy

Clinical Study ID

NCT06238518
KY20232390-C-1
  • Ages > 18
  • All Genders

Study Summary

Percutaneous coronary intervention (PCI) encounters challenges with calcified coronary lesions, leading to potential issues such as failed balloon dilatation, incomplete stent expansion, and increased risks of adverse events post-PCI, including stent restenosis and thrombosis.

Intravascular lithotripsy (IVL), a novel approach for severely calcified coronary lesion preparation, has shown promising preliminary outcomes. Combining IVL with conventional approaches, such as Rotational atherectomy (RA), non-compliant balloons, or cutting balloons, may associated with additional benefit than conventional approaches only in terms of better stent expansion and lower long-term adverse events.

This pilot randomized trial aims to investigate whether combining IVL to conventional therapy surpasses the efficacy of conventional approaches alone. The primary effectiveness endpoint is final stent expansion assessed by post-procedure optical coherence tomography (OCT), and the primary safety endpoint is target lesion failure (TVF). The trial seeks to provide valuable insights into the optimal approach for managing severely calcified coronary lesions during PCI.

Eligibility Criteria

Inclusion

Inclusion Criteria: General Inclusion Criteria:

  1. Patients with acute or chronic coronary artery syndrome indicated for PCI withstenting.
  2. Able to understand and provide informed consent and comply with all study procedures Angiographic Inclusion Criteria:
  3. Native and de novo coronary artery disease
  4. Lesion navigable by a 0.014" guidewire.
  5. Target lesion is severely calcified, meeting one of the following criteria:
  • Presence of calcium ≥ 270°, lengths ≥ 5mm, and thickness ≥ 0.5mm at onecross-section as assessed by OCT
  • If the OCT catheter is unable to pass through the target lesion after dilatationdue to calcification or tortuosity, and the target lesion is severely calcifiedon both sides of the arterial wall during angiography, with the length of thecalcification >15 mm, the lesion will be recognized as a severely calcifiedlesion, meeting the criteria for enrollment

Exclusion

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 localpractice).
  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, antiplateletdrugs, or contrast.
  7. Active bleeding.
  8. New-onset stroke or transient ischemic attack (TIA) within 90 days prior toenrollment.
  9. Severe renal dysfunction (eGFR ≤ 30 ml/min).
  10. Patients scheduled to undergo cardiac intervention or cardiac surgery within 30 daysof the index procedure.
  11. Recent ST-segment elevation myocardial infarction (STEMI) within 7 days or recentcardiogenic shock.
  12. Lesions located in surgical conduits. Angiographic Exclusion Criteria:
  13. Target vessel exhibiting C-F type dissection.
  14. Thrombosis observed by angiography or OCT.
  15. Presence of an aneurysm within 10 mm of the target lesion.
  16. Left main ostial lesion

Study Design

Total Participants: 220
Treatment Group(s): 2
Primary Treatment: Conventional lesion preparation strategy
Phase:
Study Start date:
January 05, 2024
Estimated Completion Date:
March 01, 2025

Connect with a study center

  • Ling Tao

    Xi'an, Shannxi 710032
    China

    Active - Recruiting

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