Trials / Completed
CompletedNCT03052530
Sapphire II PRO US Clinical Study
Sapphire II PRO - A Prospective, Open Label, Multi-center, Single Arm, Observational Study Designed to Evaluate the Acute Safety and Device Procedural Success of the Sapphire II PRO 1.0 and 1.25 mm PTCA Dilatation Catheters.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- OrbusNeich · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device procedural success of the Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters in subjects with stenotic coronary arteries or bypass grafts during percutaneous coronary intervention. Sixty (60) subjects will be treated at up to 5 U.S. sites with the Sapphire II PRO diameters 1.0 and 1.25 mm PTCA dilatation catheters to pre-dilate coronary arteries or bypass grafts during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through hospital discharge.
Conditions
- Coronary Artery Disease
- Coronary Disease
- Myocardial Ischemia
- Heart Diseases
- Arteriosclerosis
- Cardiovascular Diseases
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sapphire II PRO | To pre-dilate coronary arteries or bypass grafts during the subject's index procedure with Sapphire II PRO 1.0 and 1.25 PTCA dilatation catheters. |
Timeline
- Start date
- 2017-05-05
- Primary completion
- 2017-07-24
- Completion
- 2017-07-24
- First posted
- 2017-02-14
- Last updated
- 2018-05-11
- Results posted
- 2018-04-04
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03052530. Inclusion in this directory is not an endorsement.