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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: Clinical Trial Phase 2 study, sponsored by Yale University.
NCT02145299 is a Phase 2 study that was terminated before completion, run by Yale University. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Technical success, defined as the ability to facilitate complete intraluminal crossing of a CTO into the true distal lumen with a TruePath or a CROSSER device and/or any subsequent conventional guidewire, as confirmed by IVUS imaging
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 |
Why NCT02145299 stopped before completion
NCT02145299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which TruePath CTO Device is the first listed.
NCT02145299 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02145299's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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