Clinical trial NCT06238518: Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions
Official title: Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions: an Investigator-initiated, Open-label, Multicentre, Randomised, Superiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Severely Calcified Coronary Stenoses
De Novo Stenosis
Keywords: Severely Calcified Coronary Stenoses
Intravascular Lithotripsy
percutaneous coronary intervention
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, 1:1 randomized, controlled, multicenter trial to assess effectiveness and safety of adding IVL to Conventional Therapy compared to Conventional Therapy only in calcified coronary lesions.
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Final stent expansion (%) assessed by OCT
timeFrame: Measured by the data collected at the end of the PCI procedure
measure: Target vessel failure (TVF)
timeFrame: 1, 12, 36, and 60 months
Secondary outcomes:
measure: Major cardiovascular adverse events
timeFrame: 1, 12, 36, and 60 months
Other outcomes:
measure: Suboptimal stent deployment
timeFrame: Measured by the data collected at the end of the PCI procedure
measure: Stent delivery failure
timeFrame: Measured by the data collected at the end of the PCI procedure
measure: Cardiac cause death
timeFrame: 1, 12, 36, and 60 months
measure: Target vessel myocardial infarction (TV-MI)
timeFrame: 1, 12, 36, and 60 months
measure: Clinically indicated target lesion revascularization (CI-TLR)
timeFrame: 1, 12, 36, and 60 months
measure: Clinically indicated target vessel revascularization (CI-TVR)
timeFrame: 1, 12, 36, and 60 months
measure: All cause death
timeFrame: 1, 12, 36, and 60 months
measure: Any stroke
timeFrame: 1, 12, 36, and 60 months
measure: Any MI
timeFrame: 1, 12, 36, and 60 months
measure: Any revascularisation
timeFrame: 1, 12, 36, and 60 months
measure: Patient-oriented composite endpoint (PoCE)
timeFrame: 1, 12, 36, and 60 months
measure: Definite/Probable Stent thrombosis rates
timeFrame: 1, 12, 36, and 60 months
measure: Peri-procedural MI
timeFrame: 48 hours
measure: Peri-procedural major adverse events
timeFrame: 30 days
measure: Acute gain
timeFrame: Measured by the data collected at the end of the PCI procedure
measure: The difference between post- and pre-procedural FFR/IMR
timeFrame: Measured by the data collected at the end of the PCI procedure
measure: Procedure time of the PCI
timeFrame: Measured by the data collected at the end of the PCI procedure
measure: Radiation dose of the PCI
timeFrame: Measured by the data collected at the end of the PCI procedure
measure: Contrast volume
timeFrame: Measured by the data collected at the end of the PCI procedure
measure: Calcium fracture
timeFrame: Measured by the data collected at the end of the PCI procedure
measure: Angiographic success
timeFrame: Measured by the data collected at the end of the PCI procedure
measure: Strategy success
timeFrame: Measured by the data collected at the end of the PCI procedure
measure: Clinical (Procedural) success
timeFrame: 1 month
measure: Coronary flow velocity
timeFrame: Measured by the data collected at the end of the PCI procedure
measure: TIMI Flow
timeFrame: Measured by the data collected at the end of the PCI procedure
measure: Stent malapposition
timeFrame: Measured by the data collected at the end of the PCI procedure
measure: Stent volume / reference lumen volume
timeFrame: Measured by the data collected at the end of the PCI procedure
measure: Mean stent area / Mean reference lumen area
timeFrame: Measured by the data collected at the end of the PCI procedure
Locations:
city: Xi'an
country: China
facility: Ling Tao
state: Shannxi
Study officials:
affiliation: Xijing Hospital
name: Ling Tao, M.D, Ph.D.
role: STUDY_CHAIR
affiliation: Xijing Hospital
name: Chao Gao, M.D, Ph.D.
role: STUDY_CHAIR
References: