Symptomatic Femoro-popliteal Chronic Total Occlusion
Conditions
Brief 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.
Detailed description
The primary objective of the study is to compare the technical success and in-hospital safety of TruePath device with that of the CROSSER device in patients with symptomatic femoro-popliteal CTO. Subjects will be followed clinically while in the hospital and at 1 month following the index procedure. All subjects will undergo procedural intravascular ultrasound (IVUS) imaging. The study population will consist of up to 75 patients with symptomatic femoro-popliteal CTO and indications for revascularization. Subjects must have a previously documented conventional percutaneous procedure or a concurrent failed attempt to cross the CTO using conventional guidewire techniques. All subjects must meet all inclusion and no exclusion criteria and sign an Informed Consent Form approved by the local Institutional Review Board (IRB) prior to enrollment and randomization.
Interventions
DEVICETruePath CTO Device
The TruePath CTO Device is composed of a 0.018 guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions.
DEVICECROSSER CTO Device
Sponsors
Boston Scientific Corporation
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | Day of operation | 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 |
| In-hospital Safety | Operation through 30 day follow up | In-hospital safety, defined as a composite of all-cause death, index limb amputation above the ankle, and target lesion revascularization (TLR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic Improvement | Baseline, and 30 days post operation | Symptomatic improvement, as assessed by change in Rutherford Class from baseline to 30 days |
| Walking Capacity | Baseline and 30 days post operation | 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. |
| Index Limb Amputation | Day of Operation through 30 days post operation | Need for limb amputation |
| Procedural Success | Day of operation | 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 |
| Ankle-brachial Index (ABI) | baseline to 30 days post operation | The ratio of systolic blood pressure at the ankle to systolic blood pressure in the arm |
| Target Vessel Revascularization | 30 days post operation | 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). |
| Angiographic Perforation Classification and Rate | Day of operation | 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 |
| Target Lesion Revascularization | 30 days post operation | Describes the percentage of patients that had stented lesions that had to be re-treated due to clinically-driven restenosis. |
| Clinical Success | Day of operation | Clinical Success defined as procedure success in the absence of in-hospital all-cause death, index limb amputation above the ankle, and TLR. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TruePath CTO Device 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.
TruePath CTO Device: The TruePath CTO Device is composed of a 0.018 guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. | 6 |
| CROSSER CTO Device 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.
CROSSER CTO Device | 2 |
| Total | 8 |
Baseline characteristics
| Characteristic | TruePath CTO Device | CROSSER CTO Device | Total |
|---|---|---|---|
| Age, Continuous | 69.0 years STANDARD_DEVIATION 7.1 | 64.0 years STANDARD_DEVIATION 11 | 67.8 years STANDARD_DEVIATION 9.1 |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 2 |
| serious Total, serious adverse events | 0 / 6 | 0 / 2 |
Outcome results
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)
Time frame: Operation through 30 day follow up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TruePath CTO Device | In-hospital Safety | 0 percentage of participants |
| CROSSER CTO Device | In-hospital Safety | 0 percentage of participants |
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
Time frame: Day of operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TruePath CTO Device | Technical Success | 50 percentage of participants |
| CROSSER CTO Device | Technical Success | 0 percentage of participants |
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
Time frame: Day of operation
Population: These data were not fully captured and summarized as the study was terminated.
Secondary
Ankle-brachial Index (ABI)
The ratio of systolic blood pressure at the ankle to systolic blood pressure in the arm
Time frame: baseline to 30 days post operation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TruePath CTO Device | Ankle-brachial Index (ABI) | Baseline | 0.63 ratio | Standard Deviation 0.18 |
| TruePath CTO Device | Ankle-brachial Index (ABI) | 30 days | 0.68 ratio | Standard Deviation 0.24 |
| CROSSER CTO Device | Ankle-brachial Index (ABI) | Baseline | 0.75 ratio | Standard Deviation 0.19 |
| CROSSER CTO Device | Ankle-brachial Index (ABI) | 30 days | 0.93 ratio | Standard Deviation 0.07 |
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.
Time frame: Day of operation
Population: These data were not fully captured and summarized as the study was terminated.
Secondary
Index Limb Amputation
Need for limb amputation
Time frame: Day of Operation through 30 days post operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TruePath CTO Device | Index Limb Amputation | 0 participants |
| CROSSER CTO Device | Index Limb Amputation | 0 participants |
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
Time frame: Day of operation
Population: Due to early study termination for reason unrelated to safety, rather enrollment challenges, part the Procedural Success definition required % residual stenosis which was going to be a Core Laboratory assessment to eliminate bias and maintain consistency in the analysis. With only 8 subjects enrolled, laboratory analysis was not undertaken.
Secondary
Symptomatic Improvement
Symptomatic improvement, as assessed by change in Rutherford Class from baseline to 30 days
Time frame: Baseline, and 30 days post operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TruePath CTO Device | Symptomatic Improvement | 50 percentage of participants |
| CROSSER CTO Device | Symptomatic Improvement | 50 percentage of participants |
Secondary
Target Lesion Revascularization
Describes the percentage of patients that had stented lesions that had to be re-treated due to clinically-driven restenosis.
Time frame: 30 days post operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TruePath CTO Device | Target Lesion Revascularization | 0 percentage of participants |
| CROSSER CTO Device | Target Lesion Revascularization | 0 percentage of participants |
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).
Time frame: 30 days post operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TruePath CTO Device | Target Vessel Revascularization | 16.7 percentage of participants |
| CROSSER CTO Device | Target Vessel Revascularization | 0 percentage of participants |
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.
Time frame: Baseline and 30 days post operation
Population: These data were not fully captured and summarized as the study was terminated.