- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02145299
The Lumen Study: Comparing Devices for Patients With Symptomatic Femoro-popliteal Chronic Total Occlusion (CTO)
September 15, 2016 updated by: Yale University
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)
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.
Study Overview
Status
Terminated
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale Cardiovascular Research Group
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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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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Active Comparator: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technical Success
Time Frame: Day of operation
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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
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Day of operation
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In-hospital Safety
Time Frame: Operation through 30 day follow up
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In-hospital safety, defined as a composite of all-cause death, index limb amputation above the ankle, and target lesion revascularization (TLR)
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Operation through 30 day follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Procedural Success
Time Frame: Day of operation
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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
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Day of operation
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Clinical Success
Time Frame: Day of operation
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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.
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Day of operation
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Symptomatic Improvement
Time Frame: Baseline, and 30 days post operation
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Symptomatic improvement, as assessed by change in Rutherford Class from baseline to 30 days
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Baseline, and 30 days post operation
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Walking Capacity
Time Frame: Baseline and 30 days post operation
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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.
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Baseline and 30 days post operation
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Index Limb Amputation
Time Frame: Day of Operation through 30 days post operation
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Need for limb amputation
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Day of Operation through 30 days post operation
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Target Lesion Revascularization
Time Frame: 30 days post operation
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Describes the percentage of patients that had stented lesions that had to be re-treated due to clinically-driven restenosis.
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30 days post operation
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Ankle-brachial Index (ABI)
Time Frame: baseline to 30 days post operation
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The ratio of systolic blood pressure at the ankle to systolic blood pressure in the arm
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baseline to 30 days post operation
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Target Vessel Revascularization
Time Frame: 30 days post operation
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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).
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30 days post operation
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Angiographic Perforation Classification and Rate
Time Frame: Day of operation
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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
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Day of operation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Carlos Mena, MD, Yale School of Medicine
- Principal Investigator: Alexandra Lansky, MD, Yale School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
May 19, 2014
First Submitted That Met QC Criteria
May 19, 2014
First Posted (Estimate)
May 22, 2014
Study Record Updates
Last Update Posted (Estimate)
November 4, 2016
Last Update Submitted That Met QC Criteria
September 15, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- HIC140101333
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Symptomatic Femoro-popliteal Chronic Total Occlusion
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University Hospital UlmRecruitingChronic Total Occlusion | Chronic Total Occlusion of Coronary ArteryGermany
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University of ChicagoCompletedChronic Total OcclusionUnited States
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Minneapolis Heart Institute FoundationNot yet recruitingChronic Total Occlusion | OcclusionUnited States
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Ignacio J. Amat SantosCompleted
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Nitiloop Ltd.Completed
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Ureca BVTerminated
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Corindus Inc.TerminatedCoronary Artery Disease | Percutaneous Coronary Intervention | Chronic Total Occlusion of Coronary ArteryUnited States
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SoundBite Medical Solutions, Inc.Completed
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Universitätsmedizin MannheimIHF GmbH - Institut für Herzinfarktforschung; Herzzentrum LahrNot yet recruitingCoronary Artery Disease | Heart Failure | Chronic Total Occlusion
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Kerckhoff Heart CenterInstitute of Cardiology, Warsaw, Poland; University of Giessen; University Hospital...CompletedCoronary Artery DiseaseGermany, Poland
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National Institute of Cardiology, Warsaw, PolandRecruitingCoronary Artery Disease | Percutaneous Coronary Intervention | Coronary OcclusionPoland
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AngioSafe, Inc.Veranex, Inc.RecruitingPeripheral Arterial Disease | Peripheral Artery OcclusionUnited States