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NCT02145299 · ClinicalTrials.gov registry record · Phase 2
The Lumen Study: Comparing Devices for Patients With Symptomatic Femoro-popliteal Chronic Total Occlusion (CTO)
A Phase 2 study, sponsored by Yale University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT02145299 is a Phase 2 study that was terminated before completion, run by Yale University. The registered enrollment target is 8 participants.
The verdict
NCT02145299, a Phase 2 study, was terminated before completion, sponsored by Yale University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
This is a prospective, multicenter, randomized, single-blind study enrolling up to 75 subjects at up to 5 sites in the US. Eligible subjects with symptomatic femoro-popliteal CTO will be randomized 2:1 to treatment with the TruePath™ CTO Device (Intervention) or the CROSSER™ CTO device (Control). All patients will receive standard anticoagulation per hospital protocol and antiplatelet therapy with aspirin and clopidogrel.
Interventions
- DEVICE TruePath CTO Device
- DEVICE CROSSER CTO Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2014-05 |
| Est. Completion | 2015-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02145299
The ClinicalTrials.gov registry entry for NCT02145299 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TruePath CTO Device is the first listed.
NCT02145299 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02145299 about?
NCT02145299 is a clinical study titled "The Lumen Study: Comparing Devices for Patients With Symptomatic Femoro-popliteal Chronic Total Occlusion (CTO)". This is a prospective, multicenter, randomized, single-blind study enrolling up to 75 subjects at up to 5 sites in the US. Eligible subjects with symptomatic femoro-popliteal CTO will be randomized 2:1 to treatment with the TruePath™ CTO Device (Intervention) or the CROSSER™ CTO device (Control). Al...
What is the current status of trial NCT02145299?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2014-05. Estimated completion is 2015-06.
What interventions are being tested in trial NCT02145299?
The interventions under investigation include: TruePath CTO Device (DEVICE), CROSSER CTO Device (DEVICE).
Who is sponsoring clinical trial NCT02145299?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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