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NCT01925794 · ClinicalTrials.gov registry record · NA
COBRA PZF™ Coronary Stent for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term DAPT
A NA study of Coronary Artery Disease, sponsored by CeloNova BioSciences.
- Completed
- Registry status
- NA
- Development phase
- 296
- Enrollment target
- 20
- Study locations
NCT01925794: Completed NA study of Coronary Artery Disease, sponsored by CeloNova BioSciences.
NCT01925794 is a NA study of Coronary Artery Disease that has completed, run by CeloNova BioSciences. The registered enrollment target is 296 participants, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01925794, a NA study of Coronary Artery Disease, has completed, sponsored by CeloNova BioSciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 296 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a prospective, multi-center, non-randomized, single arm clinical trial that will be conducted at up to 40 sites in the United States and Outside United States (OUS). This study will enroll patients with symptomatic ischemic heart disease due to a single de novo lesion contained within a native coronary artery with reference vessel diameter between 2.5 mm and 4.0 mm and lesion length ≤ 24 mm that is amenable to percutaneous coronary intervention (PCI) and stent deployment. All patients will be followed at 30 days, 6 months, 9 months, 1 year and annually for 5 years post index stenting procedure.
Primary Outcome
TVF defined as cardiac death, target vessel myocardial infarction (MI \[Q wave or non-Q wave, ARC definition\], or clinically driven target vessel revascularization (TVR) by percutaneous or surgical methods within 270 days post-procedure.
Conditions Studied
Interventions
- DEVICE COBRA PzF
Study Locations (20)
Texas
- Cardiology Consultants of Texas - Dallas
- Plaza Medical Center - Fort Worth
- Houston Methodist Hospital - Houston
- Texas Cardiac Center - Lubbock
- The Heart Hospital Baylor Plano - Plano
- San Antonio Endovascular & Heart Institute - San Antonio
- Tyler Cardiovascular Consultants - Tyler
New York
- St Joseph's Hospital - Liverpool
- Lenox Hill Hospital - New York
- Mount Sinai Hospital - New York
California
- Bakersfield Memorial Hospital - Bakersfield
Florida
- Mt Sinai Medical Center - Miami Beach
Georgia
- Emory University Hospital - Atlanta
Indiana
- Heart Center of Indiana - Indianapolis
Louisiana
- Louisiana Heart Hospital - Lacombe
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 296 participants |
| Start Date | 2013-08-21 |
| Est. Completion | 2020-03-02 |
| Phase | NA |
What the finished NCT01925794 record still lists
NCT01925794 is an interventional study that assigns participants to a tested intervention. The registered 296 participants enrollment target is mid-sized for trials with a published cap, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which COBRA PzF is the first listed.
NCT01925794 names 20 study sites across 12 states, led by Texas, New York, California.
Frequently Asked Questions
What is clinical trial NCT01925794 about?
NCT01925794 is a clinical study titled "COBRA PZF™ Coronary Stent for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-Term DAPT". This is a prospective, multi-center, non-randomized, single arm clinical trial that will be conducted at up to 40 sites in the United States and Outside United States (OUS). This study will enroll patients with symptomatic ischemic heart disease due to a single de novo lesion contained within a nati...
What is the current status of trial NCT01925794?
This trial is currently completed. It is a NA study. The enrollment target is 296 participants. The study started on 2013-08-21. Estimated completion is 2020-03-02.
What conditions does trial NCT01925794 study?
This clinical trial studies the following conditions: Coronary Artery Disease.
What interventions are being tested in trial NCT01925794?
The interventions under investigation include: COBRA PzF (DEVICE).
Who is sponsoring clinical trial NCT01925794?
This trial is sponsored by CeloNova BioSciences, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01925794 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Coronary Artery Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01925794's enrollment target sits among peer trials
296 105th of 219 higher than 115 of 219 other Coronary Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Artery Disease 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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