Trials / Completed
CompletedNCT03763747
Scoreflex NC - Scoring PTCA Catheter
Scoreflex NC - Scoring PTCA Catheter: A Prospective, Open Label, Multi-center, Single Arm, Observational Study Designed to Evaluate the Safety and Device Procedural Success of the Scoreflex NC Scoring PTCA Catheter in Subjects With Stenotic Coronary Arteries During Percutaneous Coronary Intervention.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (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 Scoreflex NC Scoring Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters in subjects with stenotic coronary arteries during percutaneous coronary intervention. Two-hundred (200) subjects will be treated at up to 15 U.S. sites with the Scoreflex NC Scoring PTCA catheter 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 | Scoreflex NC Scoring PTCA catheter | To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters |
Timeline
- Start date
- 2019-02-27
- Primary completion
- 2019-12-27
- Completion
- 2019-12-27
- First posted
- 2018-12-04
- Last updated
- 2021-08-11
- Results posted
- 2021-08-11
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03763747. Inclusion in this directory is not an endorsement.