Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions

NCT06238518 | Unknown DMC

• 1 other identifier: KY20232390-C-1
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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

Keywords

Severely Calcified Coronary Stenoses; Intravascular Lithotripsy; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  1, 12, 36, and 60 months

Secondary Outcomes (1)

• Major cardiovascular adverse events

  1, 12, 36, and 60 months

Other Outcomes (28)

• Suboptimal stent deployment

  Measured by the data collected at the end of the PCI procedure

• Stent delivery failure

  Measured by the data collected at the end of the PCI procedure

• Cardiac cause death

  1, 12, 36, and 60 months

Study Arms (2)

Conventional lesion preparation plus Intravascular Lithotripsy strategy

EXPERIMENTAL

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

Procedure: Intravascular Lithotripsy; Procedure: Conventional lesion preparation strategy

Conventional lesion preparation strategy

ACTIVE COMPARATOR

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.

Procedure: Conventional lesion preparation strategy

Interventions

Intravascular Lithotripsy 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 plus Intravascular Lithotripsy strategy

Conventional lesion preparation strategy 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 plus Intravascular Lithotripsy strategy; Conventional lesion preparation strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with acute or chronic coronary artery syndrome indicated for PCI with stenting.
• Able to understand and provide informed consent and comply with all study procedures
• Native and de novo coronary artery disease
• Lesion navigable by a 0.014" guidewire.
• 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

You may not qualify if:

• Patients under 18 years of age.
• Incapable of providing informed consent.
• 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).
• Concurrent medical conditions with a life expectancy of less than 1 year.
• Hemodynamic instability.
• Known contraindications to medications such as Heparin, anticoagulation, antiplatelet drugs, or contrast.
• Active bleeding.
• New-onset stroke or transient ischemic attack (TIA) within 90 days prior to enrollment.
• Severe renal dysfunction (eGFR ≤ 30 ml/min).
• Patients scheduled to undergo cardiac intervention or cardiac surgery within 30 days of the index procedure.
• Recent ST-segment elevation myocardial infarction (STEMI) within 7 days or recent cardiogenic shock.
• Lesions located in surgical conduits.
• Target vessel exhibiting C-F type dissection.
• Thrombosis observed by angiography or OCT.
• Presence of an aneurysm within 10 mm of the target lesion.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Ling Tao

Xi'an, Shannxi, 710032, China

RECRUITING

Study Officials

• Ling Tao, M.D, Ph.D.

  Xijing Hospital

  STUDY CHAIR

• Chao Gao, M.D, Ph.D.

  Xijing Hospital

  STUDY CHAIR

Central Study Contacts

Chao Gao,, M.D, Ph.D

CONTACT

+86-18629551066; woshigaochao@gmail.com

Ruining Zhang, BSc

CONTACT

+86-15802990370; ruining-zhang@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Cardiology, Director of the department of Cardiology

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 2, 2024
• Study Start: January 5, 2024
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: February 2, 2024

Record last verified: 2024-01

Locations

CN (1)