Crosser Enters The Right Arterial Lumen (NCT01205386) | Clinical Trial Compass
CompletedNot Applicable
Crosser Enters The Right Arterial Lumen
United States100 participantsStarted 2010-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient must have objective evidence of lower extremity ischemia and scheduled to undergo an endovascular recanalization.
* Occluded artery must be the native superficial femoral artery.
* Patient must have a totally occlusive lesion classified angiographically as absolute (100% occlusion with no flow).
* Patient's target vessel occlusion length is ≤ 30 cm.
* Patient's reference vessel diameter is greater than or equal to 3.0mm.
* Patient must be an acceptable candidate for PTA, peripheral artery bypass surgery or peripheral artery stent implantation.
* Female patients of child bearing potential must have a negative pregnancy test within 72 hours prior to the study procedure.
* Patient or guardian must have been informed of the nature of the study, agree to its provisions, and provide written informed consent.
* Patient is ≥ 18 years of age.
Exclusion Criteria:
* Patient has hypersensitivity or contraindication to aspirin, heparin or radiographic contrast agents which cannot be adequately pre-medicated.
* The patient requires immediate treatment in more than one occluded vessel, in any combination of grafts or native vessels.
* Patient's occlusion is a flush occlusion initiating less than 2cm from the ostium.
* Patient has planned infrainguinal intervention scheduled within 30 days after index procedure.
* The patient is currently participating in another investigational drug or device trial that may conflict with study data collection and has not com…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Crosser navigates through the central lumen of the artery