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The study was stopped due to insufficient numbers of subjects to meet study design objectives.
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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TruePath CTO Device | 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 | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TruePath CTO Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Clinical Success |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Mena, MD | Yale University | Principal Investigator |
| Alexandra Lansky, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Cardiovascular Research Group | New Haven | Connecticut | 06510 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Only 8 subjects were recruited and enrolled overall- study was terminated.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | percentage of participants | Day of operation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexandra Lansky | Yale School of Medicine | 203-737-2142 | alexandra.lansky@yale.edu |
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| CROSSER CTO Device | Device |
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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 |
| Symptomatic Improvement | Symptomatic improvement, as assessed by change in Rutherford Class from baseline to 30 days | Baseline, and 30 days post operation |
| 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 |
| Index Limb Amputation | Need for limb amputation | Day of Operation through 30 days post operation |
| Target Lesion Revascularization | Describes the percentage of patients that had stented lesions that had to be re-treated due to clinically-driven restenosis. | 30 days post operation |
| 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 |
| 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 |
| 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
| Day of operation |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
| 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) | Posted | Number | percentage of participants | Operation through 30 day follow up |
|
|
|
| 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 | 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. | Posted | Day of operation |
|
|
| 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. | These data were not fully captured and summarized as the study was terminated. | Posted | Day of operation |
|
|
| Secondary | Symptomatic Improvement | Symptomatic improvement, as assessed by change in Rutherford Class from baseline to 30 days | Posted | Number | percentage of participants | Baseline, and 30 days post operation |
|
|
|
| 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. | These data were not fully captured and summarized as the study was terminated. | Posted | Baseline and 30 days post operation |
|
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| Secondary | Index Limb Amputation | Need for limb amputation | Posted | Number | participants | Day of Operation through 30 days post operation |
|
|
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| Secondary | Target Lesion Revascularization | Describes the percentage of patients that had stented lesions that had to be re-treated due to clinically-driven restenosis. | Posted | Number | percentage of participants | 30 days post operation |
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|
|
| Secondary | Ankle-brachial Index (ABI) | The ratio of systolic blood pressure at the ankle to systolic blood pressure in the arm | Posted | Mean | Standard Deviation | ratio | baseline to 30 days post operation |
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|
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| 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). | Posted | Number | percentage of participants | 30 days post operation |
|
|
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| 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
| These data were not fully captured and summarized as the study was terminated. | Posted | Day of operation |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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 | 0 | 2 | 0 | 2 |
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