Please assess the completion status of the following clinical trial:

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

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: SINGLE
- Phase: PHASE2
- Number of Arms: 2.0

Eligibility Criteria:
Inclusion Criteria:~* 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)~Exclusion Criteria:~* 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

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 100 Years
- Healthy Volunteers: f

Study Arms:
- TruePath CTO Device (Type: EXPERIMENTAL): The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018 guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.
- CROSSER CTO Device (Type: ACTIVE_COMPARATOR): The CrosserTM CTO Recanalization Catheter (Crosser system) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: terminate
termination_type: lack of efficacy