Symptomatic Femoro-popliteal Chronic Total Occlusion Clinical Trial
Official title:
A Prospective, Multicenter, Open Label Randomized Study to Evaluate the Safety, Performance and Intraluminal Crossing of the TruePath™ CTO Device Versus The Crosser System in Patients With Symptomatic Femoro-popliteal Chronic Total Occlusion (CTO)
| Verified date | January 2016 |
| Source | Yale University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 8 |
| Est. completion date | June 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 100 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Yale Cardiovascular Research Group | New Haven | Connecticut |
| Lead Sponsor | Collaborator |
|---|---|
| Yale University | Boston Scientific Corporation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Technical Success | 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 | Day of operation | No |
| Primary | In-hospital Safety | In-hospital safety, defined as a composite of all-cause death, index limb amputation above the ankle, and target lesion revascularization (TLR) | Operation through 30 day follow up | Yes |
| Secondary | Procedural Success | Procedural success, defined as technical success and (1) residual stenosis <50% in the treated segment (2) and improved distal flow by angiography following the procedure | Day of operation | No |
| Secondary | Clinical Success | Clinical Success defined as procedure success in the absence of in-hospital all-cause death, index limb amputation above the ankle, and TLR. | Day of operation | No |
| Secondary | Symptomatic improvement | Symptomatic improvement, as assessed by change in Rutherford Class from baseline to 30 days | Baseline, and 30 days post operation | No |
| Secondary | Walking Capacity | Change in walking capacity from baseline to 30 days, measured by the Walking Impairment Questionnaire. The questionaire is a subjective measure of patient-perceived walking performance developed for individuals with peripheral arterial disease. Used to evaluate the "change in walking capacity" study endpoint. | Baseline and 30 days post operation | No |
| Secondary | Index Limb Amputation | Need for limb amputation | Day of Operation through 30 days post operation | No |
| Secondary | Target Lesion Revascularization | Describes a rate measuring how many stented lesions had to be re-treated, due to clinically-driven restenosis, given a specific time period. | 30 days post operation | No |
| Secondary | Ankle-brachial index (ABI) | The ratio of systolic blood pressure at the ankle to systolic blood pressure in the arm | baseline to 30 days post operation | No |
| Secondary | Target Vessel Revascularization | A repeat revascularization procedure (percutaneous or surgical) of the index procedure target vessel. TVR is classified as clinically-driven if the repeat intervention is driven by clinical findings (ischemic symptoms). | 30 days post operation | No |
| Secondary | Angiographic perforation classification and rate | Evaluated in-hospital. The occurrence of any extravasation of contrast during the procedure (detected by the physician performing the procedure, or preferentially the Angiographic Core Laboratory) will be tabulated according to the standard Type 1-3 classification. Type 1 - Extraluminal crater without contrast extravasation Type 2 - Perivascular blush without contrast jet extravasation Type 3 - Contrast jet extravasation through frank (=1 mm) perforation |
Day of operation | No |