Trial Outcomes & Findings for The Lumen Study: Comparing Devices for Patients With Symptomatic Femoro-popliteal Chronic Total Occlusion (CTO) (NCT NCT02145299)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Day of operation

Results posted on

2016-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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
Overall Study STARTED	6	2
Overall Study COMPLETED	6	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TruePath CTO Device n=6 Participants 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.	CROSSER CTO Device n=2 Participants 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	Total n=8 Participants Total of all reporting groups
Age, Continuous	69.0 years STANDARD_DEVIATION 7.1 • n=5 Participants	64.0 years STANDARD_DEVIATION 11.0 • n=7 Participants	67.8 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	TruePath CTO Device n=6 Participants 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.	CROSSER CTO Device n=2 Participants 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
Technical Success	50 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	TruePath CTO Device n=6 Participants 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.	CROSSER CTO Device n=2 Participants 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
In-hospital Safety	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day of operation

Population: These data were not fully captured and summarized as the study was terminated.

Clinical Success defined as procedure success in the absence of in-hospital all-cause death, index limb amputation above the ankle, and TLR.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, and 30 days post operation

Symptomatic improvement, as assessed by change in Rutherford Class from baseline to 30 days

Outcome measures

Outcome measures
Measure	TruePath CTO Device n=6 Participants 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.	CROSSER CTO Device n=2 Participants 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
Symptomatic Improvement	50 percentage of participants	50 percentage of participants

SECONDARY outcome

Timeframe: Baseline and 30 days post operation

Population: These data were not fully captured and summarized as the study was terminated.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day of Operation through 30 days post operation

Need for limb amputation

Outcome measures

Outcome measures
Measure	TruePath CTO Device n=6 Participants 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.	CROSSER CTO Device n=2 Participants 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
Index Limb Amputation	0 participants	0 participants

SECONDARY outcome

Timeframe: 30 days post operation

Describes the percentage of patients that had stented lesions that had to be re-treated due to clinically-driven restenosis.

Outcome measures

Outcome measures
Measure	TruePath CTO Device n=6 Participants 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.	CROSSER CTO Device n=2 Participants 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
Target Lesion Revascularization	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: baseline to 30 days post operation

The ratio of systolic blood pressure at the ankle to systolic blood pressure in the arm

Outcome measures

Outcome measures
Measure	TruePath CTO Device n=6 Participants 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.	CROSSER CTO Device n=2 Participants 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
Ankle-brachial Index (ABI) Baseline	0.63 ratio Standard Deviation 0.18	0.75 ratio Standard Deviation 0.19
Ankle-brachial Index (ABI) 30 days	0.68 ratio Standard Deviation 0.24	0.93 ratio Standard Deviation 0.07

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	TruePath CTO Device n=6 Participants 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.	CROSSER CTO Device n=2 Participants 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
Target Vessel Revascularization	16.7 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Day of operation

Population: These data were not fully captured and summarized as the study was terminated.

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

Outcome measures

Outcome data not reported

Adverse Events

TruePath CTO Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CROSSER CTO Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alexandra Lansky

Yale School of Medicine

Phone: 203-737-2142

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place