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NCT06358508 · ClinicalTrials.gov registry record · NA
Sapphire 3 CTO Study
A NA study of Cardiovascular Diseases and Coronary Artery Disease, sponsored by OrbusNeich.
- Completed
- Registry status
- NA
- Development phase
- 170
- Enrollment target
- 14
- Study locations
NCT06358508: Completed NA study of Cardiovascular Diseases and Coronary Artery Disease, sponsored by OrbusNeich.
NCT06358508 is a NA study of Cardiovascular Diseases and Coronary Artery Disease that has completed, run by OrbusNeich. The registered enrollment target is 170 participants, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (99% lower). The trial reports 14 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06358508, a NA study of Cardiovascular Diseases and Coronary Artery Disease, has completed, sponsored by OrbusNeich.
- COMPLETED
- Registry status
- NA
- Development phase
- 170 participants
- Enrollment target
- 14
- Study locations
Study Summary
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.
Primary Outcome
Device procedural success consisting of the following: * Successful delivery, inflation, deflation and withdrawal of the study balloon and after the guidewire has successfully crossed the CTO lesion into the true lumen of the vessel * No evidence of vessel perforation or dissections (Grade C or higher) related to the study balloon * Final TIMI flow grade of II or III at the conclusion of the PCI procedure
Conditions Studied
Interventions
- DEVICE Sapphire 3 Coronary Dilatation Catheter
Study Locations (14)
Georgia
- Emory University Hospital Midtown - Atlanta
- Piedmont Heart Institute - Atlanta
- Emory University Hospital - Atlanta
- Emory St. Joseph's Hospital - Atlanta
- Atlanta VA Health Care System - Decatur
California
- Stanford Health Care - Stanford
- Torrance Memorial Medical Center - Torrance
Massachusetts
- Massachusetts General Hospital - Boston
- Brigham and Women's Hospital Heart and Vascular Center - Boston
Other
- Hospital Universitari de Bellvitge - Barcelona
- Hospital Clinico Universitario de Valladolid - Valladolid
Michigan
- Henry Ford Health System - Detroit
Minnesota
- Minneapolis Heart Institute Foundation - Minneapolis
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2024-11-06 |
| Est. Completion | 2025-10-21 |
| Phase | NA |
What the finished NCT06358508 record still lists
NCT06358508 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (99% lower).
The record links to 8 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 1 intervention - of which Sapphire 3 Coronary Dilatation Catheter is the first listed.
NCT06358508 lists 14 locations in 7 states (Georgia, California, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT06358508 about?
NCT06358508 is a clinical study titled "Sapphire 3 CTO Study". 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 in...
What is the current status of trial NCT06358508?
This trial is currently completed. It is a NA study. The enrollment target is 170 participants. The study started on 2024-11-06. Estimated completion is 2025-10-21.
What conditions does trial NCT06358508 study?
This clinical trial studies the following conditions: Cardiovascular Diseases, Coronary Artery Disease, Heart Diseases, Coronary Disease, Myocardial Ischemia.
What interventions are being tested in trial NCT06358508?
The interventions under investigation include: Sapphire 3 Coronary Dilatation Catheter (DEVICE).
Who is sponsoring clinical trial NCT06358508?
This trial is sponsored by OrbusNeich, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06358508 being conducted?
This trial has 14 study locations across California, Georgia, Massachusetts, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06358508's enrollment target sits among peer trials
170 163rd of 300 higher than 138 of 300 other Cardiovascular Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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