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NCT06936189
Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)(Extended Follow-Up)
trial in Carotid Artery Stenosis in 204 participants. Currently enrolling.
30 December 2027
Quick facts
| Lead sponsor | Shanghai Bluesail Boyuan Medical Technology Co., Ltd. |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 204 |
| Start date | 12 May 2025 |
| Primary completion | 30 December 2027 |
| Estimated completion | 30 December 2027 |
| Sites | 1 location across China |
Conditions studied
- Carotid Artery Stenosis — all drugs for Carotid Artery Stenosis →
Sponsor
Shanghai Bluesail Boyuan Medical Technology Co., Ltd. — full company profile →
Who can join
Adults 18 to 80, any sex, with Carotid Artery Stenosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Purpose: To assess the long-term safety and efficacy of the intravascular lithotripsy system for pre-treatment of calcified carotid artery stenosis. Design: Prospective, multicenter, single-arm study with an extended follow-up period. Sample Size: 204 participants (based on the final number of cases enrolled in the registration trial). Endpoints: Primary: Surgical success rate (residual stenosis \<30% after stenting). Secondary: Target lesion re-narrowing rate, target lesion revascularization rate, MAE rate, ipsilateral stroke rate, and MACCE rate at 3 and 6 months postoperatively. Follow-Up: Participants will be followed up at 3 months ±15 days and 6 months ±30 days postoperatively. Inclusion criteria: All patients participating in this extended follow-up period are sourced from the registered clinical trial. Ethics and Consent: The trial will be conducted in accordance with the Helsinki Declaration and Chinese regulations. Informed consent will be obtained from all participants or their legal guardians. Sponsor: Shanghai Lanfan Boyuan Medical Technology Co., Ltd. Principal Investigator: Professor Huo Xiaochuan, Beijing Anzhen Hospital.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06936189
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other recruiting trials for Carotid Artery Stenosis
Currently open trials in the same condition.
- NCT07370246 — CAS for Stenosis With High-risk Features for CEA · NA · recruiting
- NCT07247864 — Balloon Guide Catheter Combined With Filter Protection for Carotid Artery Stenting · NA · recruiting
- NCT06924593 — Study on the Trans-Carotid Artery Occlusion Shunt System · NA · recruiting
- NCT07034157 — A Real-World Study on Ultrasound-Based Screening and Integrated Therapeutic Strategies for Patients With Concomitant Cor · recruiting
- NCT06936176 — Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial) · NA · recruiting
Other Shanghai Bluesail Boyuan Medical Technology Co., Ltd. trials
Trials by the same sponsor.
- NCT07388030 — Lithotripsy Versus Balloon Angioplasty for Optimal Treatment of CAlcified Lesions With and Without Optical Coherence Tom · NA · not yet recruiting
- NCT06924736 — SONICURE（SONICracker for the Treatment of UndeRExpansion） · NA · not yet recruiting
- NCT06936176 — Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial) · NA · recruiting
- NCT05649488 — Evaluate the Safety and Efficacy of Intracoronary Lithotripsy Balloon Catheter and Intracoronary Lithotripsy Apparatus · NA · unknown
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 NCT06936189 (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 Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
- Last refreshed: 16 May 2025
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/NCT06936189.
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