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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06358508
The ClinicalTrials.gov registry entry for NCT06358508 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 170 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (99% lower). The listed sponsor is OrbusNeich, which has 4 total studies on file at ClinicalTrials.gov.
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 reports 14 study locations spanning 7 distinct geographic areas - top geographies include 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.
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