Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions

Xijing Hospital220 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

220

Conditions

Severely Calcified Coronary Stenoses De Novo Stenosis

Interventions

Intravascular LithotripsyPROCEDURE

The size of the IVL balloon catheter is selected in a 1:1 ratio to the distal reference vessel diameter. The balloon catheter is then inflated to 4 atm, and 10 impulses are delivered. Subsequently, the balloon is inflated to 8 atm and then deflated to re-establish blood flow. Up to 100 impulses can be delivered, and the balloon can be repositioned within the lesion. In cases involving multiple lesions with different reference vessel diameters, various sizes of IVL balloons may be employed. If the IVL balloon catheter is unable to pass through the lesion, pre-dilatation can be performed using a smaller diameter noncompliant balloon or rotational atherectomy.

Conventional lesion preparation strategyPROCEDURE

Conventional lesion preparation strategy includes the use of Compliant, noncompliant, cutting, or scoring balloons, Excimer laser coronary atherectomy, or Rotational atherectomy at the discretion of the operator.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Final stent expansion (%) assessed by OCT

The primary efficacy endpoint of the trial is the Final stent expansion %, defined as the minimum stent area (MSA) / mean reference lumen area assessed by OCT.

Time frame: Measured by the data collected at the end of the PCI procedure

Target vessel failure (TVF)

The primary safety endpoint of the trial is target vessel failure (TVF), defined as a non-hierarchical composite endpoint of cardiovascular death, target-vessel myocardial infarction (TV-MI), and clinically indicated target vessel revascularization (CI-TVR).

Time frame: 1, 12, 36, and 60 months

Secondary Outcomes

Major cardiovascular adverse events

Major adverse cardiovascular events (MACE) is defined as a hierarchical composite of cardiovascular death, target-vessel myocardial infarction, clinically indicated target vessel revascularization, stent delivery failure, and suboptimal stent deployment. The between-group difference in terms of MACE will be compared using the Win Ratio approach in the abovementioned order.