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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 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.

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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.

Conditions Studied

Coronary Artery Disease

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

FieldValue
Enrollment Target 296 participants
Start Date 2013-08-21
Est. Completion 2020-03-02
Phase NA

Sponsor

CeloNova BioSciences

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01925794

The ClinicalTrials.gov registry entry for NCT01925794 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 296 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (77% lower). The listed sponsor is CeloNova BioSciences, which has 1 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.