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NCT01205386 · ClinicalTrials.gov registry record
Crosser Enters The Right Arterial Lumen
A clinical trial of Chronic Total Occlusion of Artery of the Extremities, sponsored by C. R. Bard.
- Completed
- Registry status
- 100
- Enrollment target
- 8
- Study locations
NCT01205386: Completed study of Chronic Total Occlusion of Artery of the Extremities, sponsored by C. R. Bard.
NCT01205386 is a study of Chronic Total Occlusion of Artery of the Extremities that has completed, run by C. R. Bard. The registered enrollment target is 100 participants. The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01205386, a study of Chronic Total Occlusion of Artery of the Extremities, has completed, sponsored by C. R. Bard.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purpose of this study is to determine if the CROSSER CTO Recanalization System can facilitate the successful crossing of Chronic Total Occlusions in the Central lumen of the Superficial Femoral Artery (SFA). A Chronic Total Occlusion (CTO) is defined as 100% narrowing of the artery, with no angiographically detectable antegrade blood flow, and the assessment that the lesion has been in existence for a minimum of 30 days. This study will enroll up to 100 patients at up to 8 clinical sites. The CROSSER CTO Recanalization System was cleared for commercialization by the US Food \& Drug Administration. This study also involves an imaging device called the IVUS (Intravascular Ultrasound Imaging) catheter. This device has been cleared for commercialization by the US Food and Drug Administration and will be studied for its cleared intended use. The IVUS catheter is used to generate real-time images of the artery, which will allow for evaluation of the artery after the occlusion is crossed. This is a post-market registry.
Primary Outcome
Successful navigation of the CROSSER CTO Recanalization Catheter in the central lumen of the artery as confirmed by Intravascular Ultrasound (IVUS) following recanalization
Conditions Studied
Interventions
- DEVICE 1. CROSSER System
Study Locations (8)
Michigan
- St. John Hospital and Medical Center - Detroit
- Metro Health Hospital - Wyoming
District of Columbia
- Washington Hospital Center - Washington D.C.
Iowa
- Iowa Methodist Medical Center - Des Moines
Minnesota
- Mercy Heart and Vascular Center - Coon Rapids
New York
- Columbia University Medical Center - New York
Ohio
- The Christ Hospital - Cincinnati
Tennessee
- Memphis Heart Clinic - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2010-02 |
| Est. Completion | 2012-08 |
What the finished NCT01205386 record still lists
NCT01205386 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Chronic Total Occlusion of Artery of the Extremities appearing as the primary indexed condition, and to 1 intervention - of which 1. CROSSER System is the first listed.
NCT01205386 lists 8 locations in 7 states (Michigan, District of Columbia, Iowa).
Frequently Asked Questions
What is clinical trial NCT01205386 about?
NCT01205386 is a clinical study titled "Crosser Enters The Right Arterial Lumen". The purpose of this study is to determine if the CROSSER CTO Recanalization System can facilitate the successful crossing of Chronic Total Occlusions in the Central lumen of the Superficial Femoral Artery (SFA). A Chronic Total Occlusion (CTO) is defined as 100% narrowing of the artery, with no angi...
What is the current status of trial NCT01205386?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2010-02. Estimated completion is 2012-08.
What conditions does trial NCT01205386 study?
This clinical trial studies the following conditions: Chronic Total Occlusion of Artery of the Extremities.
What interventions are being tested in trial NCT01205386?
The interventions under investigation include: 1. CROSSER System (DEVICE).
Who is sponsoring clinical trial NCT01205386?
This trial is sponsored by C. R. Bard, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01205386 being conducted?
This trial has 8 study locations across District of Columbia, Iowa, Michigan, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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