Clinical Trial on the Treatment of Stent Underexpansion Caused by Calcification Using Intravascular Lithotripsy

StatusUnknown
PhaseNot applicable
Started

Record status This record was last updated July 29, 2024 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

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Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Jul 2024); last known: Not Yet Recruiting
  2. Secondary endpoints: details revised at 3 of 3 entriesv2
  3. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Our aim is to investigate the efficacy and safety of intravascular lithotripsy(IVL) in the treatment of stent underexpansion caused by calcification through a prospective, multicenter, randomized controlled trial. Patients with inadequate stent expansion due to calcification detected by intravascular ultrasound(IVUS) were randomly divided into two groups. The experimental group received IVL in addition to high-pressure balloon post-dilation, while the control group only received high-pressure balloon post-dilation. Follow up for 1 year is conducted to determine the safety and efficacy of IVL application based on the primary efficacy endpoint, key secondary efficacy endpoint, other secondary efficacy endpoint, and safety endpoint.
Trial Details
NCT Number NCT06521905
Lead Sponsor China National Center for Cardiovascular Diseases
Conditions
(from sponsor)		 Intravascular Lithotripsy
Enrollment 222 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov