Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions: an Investigator-initiated, Open-label, Multicentre, Randomised, Superiority Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

∙ Angiographic Inclusion Criteria:

• 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

Locations
Other Locations
China
Ling Tao
RECRUITING
Xi'an
Contact Information
Primary
Chao Gao,, M.D, Ph.D
woshigaochao@gmail.com
+86-18629551066
Backup
Ruining Zhang, BSc
ruining-zhang@qq.com
+86-15802990370
Time Frame
Start Date: 2024-01-05
Estimated Completion Date: 2025-03-01
Participants
Target number of participants: 220
Treatments
Experimental: 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.
Active_comparator: 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.
Sponsors
Leads: Xijing Hospital

This content was sourced from clinicaltrials.gov