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NCT06669793
Biolimus-Coated Balloon in de Novo Large Vessel Coronary Lesions
NA trial testing biolimus-coated balloon in Coronary Arterial Disease (CAD) in 475 participants. Not yet recruiting.
23 May 2027
Quick facts
| Lead sponsor | Xuzhou Third People's Hospital |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 475 |
| Start date | 10 December 2024 |
| Primary completion | 23 May 2027 |
| Estimated completion | 23 May 2028 |
Drugs / interventions tested
- biolimus-coated balloon
- paclitaxel-coated balloon
Conditions studied
- Coronary Arterial Disease (CAD) — all drugs for Coronary Arterial Disease (CAD) →
Sponsor
Xuzhou Third People's Hospital
Who can join
Adults 18 to 80, any sex, with Coronary Arterial Disease (CAD). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Percutaneous coronary intervention (PCI) is one of the standard treatments for patients with acute and chronic coronary syndromes that are consistently recommended by current national and international guidelines. Currently, even with the most advanced design concepts of drug-eluting stents (DES), the permanent foreign body and in-stent restenosis after implantation are still very detrimental to the clinical outcomes of patients. These problems have been mitigated to some extent by the advent of the drug-coated balloon (DCB), a special balloon coated with an antiproliferative drug that is uniformly delivered to the vessel wall during endovascular dilatation to inhibit endothelial proliferation. This study is a prospective randomized study of a novel drug-coated balloon for the treatment of de novo coronary artery large vessel lesions. By comparing the clinical outcomes of the novel BA9 drug-coated balloon (BCB) with those of the paclitaxel-coated balloon (PCB) in the treatment of de novo coronary artery large vessel, we evaluated the safety and efficacy of the BCB for such lesions, and provided evidence for the later use of rapamycin-based drug-coated balloons in PCI. They are randomly dividing them into BCB treatment group and PCB treatment group according to the ratio of 1:1. All subjects accept clinical follow-up after operation, at 30 days, 6 months, 9 months and 12 months after operation.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06669793
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
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Currently open trials in the same condition.
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Other Xuzhou Third People's Hospital trials
Trials by the same sponsor.
- NCT07162792 — The Safety and Efficacy of New-Generation BRS vs. DCB for De Novo Large Coronary Artery Lesions: A Prospective RCT · NA · not yet recruiting
- NCT06669195 — Intravascular Lithotripsy for Acute Stent Under-expansion in Calcified Coronary Lesions · NA · not yet recruiting
- NCT06166459 — Yao Strategy for the Treatment of de Novo Medina 0,1,0 or 0,0,1 Bifurcation Lesion · NA · unknown
- NCT04375319 — OCT Evaluation of Early Vascular Repair in Patients With Non ST Elevation Acute Coronary Syndrome (NSTE-ACS) · NA · unknown
- NCT04641468 — Clinical Efficacy and Safety of a Prospective, Multicenter Drug Coated Balloon for Left Main Artery Disease in China · 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 NCT06669793 (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 Xuzhou Third People's Hospital
- Last refreshed: 1 November 2024
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