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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale Cardiovascular Research Group

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: 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.
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.
Device: CROSSER CTO Device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Technical Success
Time Frame: 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
Day of operation
In-hospital Safety
Time Frame: 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)
Operation through 30 day follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedural Success
Time Frame: 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
Day of operation
Clinical Success
Time Frame: 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.
Day of operation
Symptomatic Improvement
Time Frame: Baseline, and 30 days post operation
Symptomatic improvement, as assessed by change in Rutherford Class from baseline to 30 days
Baseline, and 30 days post operation
Walking Capacity
Time Frame: 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.
Baseline and 30 days post operation
Index Limb Amputation
Time Frame: Day of Operation through 30 days post operation
Need for limb amputation
Day of Operation through 30 days post operation
Target Lesion Revascularization
Time Frame: 30 days post operation
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)
Time Frame: baseline to 30 days post operation
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
Time Frame: 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).
30 days post operation
Angiographic Perforation Classification and Rate
Time Frame: 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
Day of operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boston Scientific Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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