Last reviewed · How we verify
NCT06358508
Sapphire 3 CTO Study
NA trial testing Sapphire 3 Coronary Dilatation Catheter in Coronary Artery Disease in 170 participants. Completed in 21 October 2025.
21 October 2025
Quick facts
| Lead sponsor | OrbusNeich |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 170 |
| Start date | 6 November 2024 |
| Primary completion | 21 October 2025 |
| Estimated completion | 21 October 2025 |
| Sites | 14 locations across United States, Spain |
Drugs / interventions tested
- Sapphire 3 Coronary Dilatation Catheter
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- Coronary Disease — all drugs for Coronary Disease →
- Myocardial Ischemia — all drugs for Myocardial Ischemia →
- Heart Diseases — all drugs for Heart Diseases →
Sponsor
OrbusNeich — full company profile →
Who can join
18 and older, any sex, with Coronary Artery Disease or Coronary Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device performance of the Sapphire 3 0.85, 1.0 and 1.25mm diameter coronary dilatation catheter in predilatation of Chronic Total Occlusion (CTO) lesions during percutaneous coronary intervention. One hundred seventy (170) subjects will be enrolled with a target of one hundred fifty-three (153) evaluable subjects by the angiographic core laboratory at up to 15 clinical sites with the Sapphire 3 0.85, 1.0 and 1.25mm diameter PTCA dilatation catheter to pre-dilate CTO lesions in coronary arteries during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through study completion, which is defined as 24-hours post-procedure or hospital discharge, whichever comes first.
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 NCT06358508
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Coronary Artery Disease
Currently open trials in the same condition.
- NCT07399002 — LONG NAGOMI™ PMCF STUDY · recruiting
- NCT07420582 — Antegrade Autologous Blood Reinfusion After CPB · recruiting
- NCT07493603 — A Study on Yiyang Huoluo Decoction in the Treatment of Coronary Heart Disease · Phase 1, PHASE2 · recruiting
- NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO · NA · recruiting
- NCT07286578 — A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Under · NA · recruiting
Other OrbusNeich trials
Trials by the same sponsor.
- NCT05929313 — Scoreflex TRIO - Scoring PTCA Catheter · NA · completed
- NCT03763747 — Scoreflex NC - Scoring PTCA Catheter · NA · completed
- NCT03052530 — Sapphire II PRO US Clinical Study · 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 NCT06358508 (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 OrbusNeich
- Last refreshed: 12 January 2026
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/NCT06358508.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing