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Crosser Enters The Right Arterial Lumen
NCT01205386 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01205386
The ClinicalTrials.gov registry entry for NCT01205386 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is C. R. Bard, which has 46 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01205386 reports 8 study locations spanning 7 distinct geographic areas — top geographies include Michigan, District of Columbia, Iowa. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01205386?
The interventions under investigation include: 1. CROSSER System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01205386?
This trial is sponsored by C. R. Bard, which has 46 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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