The Lumen Study: Comparing Devices for Patients With Symptomatic Femoro-popliteal Chronic Total Occlusion (CTO)

Stopped early · Phase 2

Conditions studied: Symptomatic Femoro-popliteal Chronic Total Occlusion

In brief

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.

Key facts

Study ID

NCT02145299

Run by

Yale University

People needed

8

Starts

2014-05-01

Expected to finish

2015-06-01

Last updated by the study team

2016-11-04

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical Inclusion Criteria
• Male or non-pregnant female ≥18 years of age;
• Rutherford Clinical Category 2-5
• Patients is willing to provide informed consent and comply with the required follow-up visits, testing schedule, and medication regimen
• Angiographic Lesion Inclusion Criteria
• Length ≤35 cm
• The lesion is a single lesion or composite of multiple lesions within the 35 cm segment
• 100% stenosis by visual estimate
• Previously documented conventional percutaneous procedure or a concurrent failed attempt to cross the CTO using conventional guidewire techniques
• Ability to visualize target artery distal to the lesion (via collateral circulation)
• Target lesion located in the superficial femoral/proximal popliteal arteries, with lesion location starting ≥1cm below the common femoral bifurcation
• De novo lesion or restenotic lesion >30 days from any prior endovascular intervention
• Target vessel diameter ≥4 and ≤7 mm and able to be treated with PTA and or a stent
• A patent inflow artery free from significant lesions (≥50% stenosis) as confirmed by angiography. Treatment of the target lesion may be performed after successful treatment of existing inflow artery lesions at the time of the index procedure. [NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤50% without death or major vascular complication.]
• At least one patent outflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is permitted)

You may not qualify if…

• Pregnant or nursing subjects and those who plan pregnancy in the period up to 3 months following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done prior to the index procedure.
• Rutherford Class 0, 1 or 6
• History of hemorrhagic stroke within 3 months
• Renal failure or chronic kidney disease with MDRD GFR ≤ 30 ml/min per 1.73m2 (or serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis)
• Previous or planned surgical or interventional procedure to the target limb within 2 weeks before (aside from conventional percutaneous procedure during the current hospitalization) or within 30 days after the index procedure
• Prior vascular surgery of the index limb, with the exception of common femoral patch angioplasty remote from the target lesion
• Planned use of adjunctive primary treatment modalities (e.g., laser, atherectomy, cryoplasty, scoring/cutting balloon, or other)
• Inability to take required study medications or an allergy to contrast that cannot be controlled with medication
• Life expectancy of <1 years
• Patient is currently participating in an investigational drug or device study or previously enrolled in this study Subject enrollment and treatment

Where it is running

• Yale Cardiovascular Research Group — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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