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NCT06238518: REC-CHIPCAC
Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions
NA trial testing Intravascular Lithotripsy in Severely Calcified Coronary Stenoses in 220 participants. Status unknown.
1 December 2024
Quick facts
| Lead sponsor | Xijing Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 220 |
| Start date | 5 January 2024 |
| Primary completion | 1 December 2024 |
| Estimated completion | 1 March 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Intravascular Lithotripsy
- Conventional lesion preparation strategy
Conditions studied
- Severely Calcified Coronary Stenoses — all drugs for Severely Calcified Coronary Stenoses →
- De Novo Stenosis — all drugs for De Novo Stenosis →
Sponsor
Xijing Hospital
Who can join
18 and older, any sex, with Severely Calcified Coronary Stenoses or De Novo Stenosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06238518
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Intravascular Lithotripsy
Trials testing the same drug.
- NCT07109479 — Safety and Effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter Combined With the Intrava · NA · not yet recruiting
- NCT06089135 — Shockwave Lithoplasty Compared to Cutting Balloon Treatment in Calcified Coronary Disease - A Randomized Controlled Tria · NA · completed
- NCT05858905 — FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter · NA · completed
- NCT05662787 — BOLT Lithotripsy RESTORE ATK Trial · NA · completed
- NCT05535907 — BOLT Lithotripsy RESTORE BTK Trial · NA · completed
Other recruiting trials for Severely Calcified Coronary Stenoses
Currently open trials in the same condition.
- NCT06678594 — Implementation of a Standardized Algorithm for Coronary Calcification With Plaque Modification · recruiting
Other Xijing Hospital trials
Trials by the same sponsor.
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- NCT07519018 — TIS for Drug Resistant TLE · NA · not yet recruiting
- NCT07518992 — Correlation Between Preoperative Sleep and Postoperative Brain and Renal Dysfunction · not yet recruiting
- NCT07466303 — Serplulimab Combined With Trastuzumab Rezetecan as Neoadjuvant Therapy for Triple-Negative Breast Cancer · Phase 2 · not yet recruiting
- NCT07474142 — A Multicenter, Prospective Study on the Prognostic Value of PSMA PET in Patients With Newly Diagnosed, Treatment-naïve P · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06238518 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xijing Hospital
- Last refreshed: 2 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06238518.
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