Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions

Not Applicable

Recruiting

• Conditions: De Novo Stenosis; Severely Calcified Coronary Stenoses
• Interventions: Procedure: Conventional lesion preparation strategy; Procedure: Intravascular Lithotripsy

• Registration Number: NCT06238518
• Lead Sponsor: Xijing Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-05
• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-01-25
• Last Update Submitted: 2024-01-25
• Study First Posted: 2024-02-02
• Last Update Posted: 2024-02-02
• Primary Completion: 2024-12-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional lesion preparation strategy	Conventional lesion preparation strategy	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.
Conventional lesion preparation plus Intravascular Lithotripsy strategy	Intravascular Lithotripsy	IVL could be performed before, amidst, or after Conventional lesion preparation therapy; However, the use of IVL treatment is mandatory.
Conventional lesion preparation plus Intravascular Lithotripsy strategy	Conventional lesion preparation strategy	IVL could be performed before, amidst, or after Conventional lesion preparation therapy; However, the use of IVL treatment is mandatory.

Primary Outcome Measures

Name	Time	Method
Final stent expansion (%) assessed by OCT	Measured by the data collected at the end of the PCI procedure	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.
Target vessel failure (TVF)	1, 12, 36, and 60 months	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).

Secondary Outcome Measures

Name	Time	Method
Major cardiovascular adverse events	1, 12, 36, and 60 months	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.

Trial Locations

Locations (1)

Ling Tao; 🇨🇳 Xi'an, Shannxi, China