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NCT05998252
Evaluate Safety and Efficacy of Alveo HP Balloon Dilatation Catheter for Balloon Dilatation of Coronary Artery Stenosis
NA trial testing Alveo HP Balloon Dilatation Catheter in Coronary Artery Disease in 60 participants. Completed in 8 December 2023.
29 August 2023
Quick facts
| Lead sponsor | BrosMed Medical Co., Ltd |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 27 December 2022 |
| Primary completion | 29 August 2023 |
| Estimated completion | 8 December 2023 |
| Sites | 3 locations across China |
Drugs / interventions tested
- Alveo HP Balloon Dilatation Catheter
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
Sponsor
BrosMed Medical Co., Ltd
Who can join
18 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective, multi-center, single-group study aims to evaluate the safety and efficacy of Alveo HP Balloon Dilatation Catheter for balloon dilatation of coronary artery stenosis. Pre-dilation with Alveo balloon dilatation catheter followed by conventional PCI, and follow-up will be carried out. During the trial, the enrollment, treatment and follow-up of the subjects will be recorded, and the safety and efficacy of the investigational device will be evaluated.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05998252
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other BrosMed Medical Co., Ltd trials
Trials by the same sponsor.
- NCT07187128 — A Post-Market Study of Drug-Coated Peripheral Balloon Dilatation Catheter in Treating Femoropopliteal Artery Stenosis or · NA · not yet recruiting
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- NCT06214754 — Efficacy and Safety of Intravascular High-pressure Cutting Balloon Catheters for PCI · NA · completed
- NCT05747287 — Evaluate Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions · NA · completed
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 NCT05998252 (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 BrosMed Medical Co., Ltd
- Last refreshed: 10 January 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/NCT05998252.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing