Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions

NCT ID: NCT06238518

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-05
• Study Completion Date: 2025-03-01

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.

Conditions

Severely Calcified Coronary Stenoses; De Novo Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional lesion preparation plus Intravascular Lithotripsy strategy

IVL could be performed before, amidst, or after Conventional lesion preparation therapy; However, the use of IVL treatment is mandatory.

Group Type: EXPERIMENTAL

Intravascular Lithotripsy

Intervention Type: PROCEDURE

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 strategy

Intervention Type: PROCEDURE

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 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.

Group Type: ACTIVE_COMPARATOR

Conventional lesion preparation strategy

Intervention Type: PROCEDURE

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.

Interventions

Intravascular Lithotripsy

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

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

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

LingTao

Professor in Cardiology, Director of the department of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ling Tao, M.D, Ph.D.

Role: STUDY_CHAIR

Xijing Hospital

Chao Gao, M.D, Ph.D.

Role: STUDY_CHAIR

Xijing Hospital

Locations

Ling Tao

Xi'an, Shannxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chao Gao,, M.D, Ph.D

Role: CONTACT

woshigaochao@gmail.com

+86-18629551066

Ruining Zhang, BSc

Role: CONTACT

ruining-zhang@qq.com

+86-15802990370

Facility Contacts

Chao Gao

Role: primary

woshigaochao@gmail.com

Other Identifiers

KY20232390-C-1

Identifier Type: -

Identifier Source: org_study_id