Symptomatic Femoro-popliteal Chronic Total OcclusionPhase 2NCT02145299

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

A Phase 2 study testing TruePath CTO Device and CROSSER CTO Device in people with Symptomatic Femoro-popliteal Chronic Total Occlusion, run by Yale University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Symptomatic Femoro-popliteal Chronic Total Occlusion
What is being tested?: TruePath CTO Device and CROSSER CTO Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: May 2014to Jun 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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)

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale Cardiovascular Research Group
New Haven, Connecticut, 06510

Other trials in United States

About this study

Official title: 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)

Read the 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.

Conditions: Symptomatic Femoro-popliteal Chronic Total Occlusion
Being tested: TruePath CTO Device, CROSSER CTO Device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TruePath CTO DeviceDevice
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 DeviceDevice

Study groups in NCT02145299
Study group	Role	What they receive
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. Receives: Device: TruePath CTO Device
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. Receives: Device: CROSSER CTO Device

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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)
Measured: Operation through 30 day follow up

Secondary outcomes (9)

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
Measured: Day of operation
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.
Measured: Day of operation
Symptomatic Improvement
Symptomatic improvement, as assessed by change in Rutherford Class from baseline to 30 days
Measured: 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.
Measured: Baseline and 30 days post operation
Index Limb Amputation
Need for limb amputation
Measured: 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.
Measured: 30 days post operation
Ankle-brachial Index (ABI)
The ratio of systolic blood pressure at the ankle to systolic blood pressure in the arm
Measured: 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).
Measured: 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
- Type 2 - Perivascular blush without contrast jet extravasation
- Type 3 - Contrast jet extravasation through frank (≥1 mm) perforation
Measured: Day of operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Jun 2015

First posted22 May 2014 (estimated)
Study startMay 2014
Primary completionMar 2015
Study completionJun 2015

Why it stopped: The study was stopped due to insufficient numbers of subjects to meet study design objectives.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Symptomatic Femoro-popliteal Chronic Total OcclusionStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02145299
Sponsor's protocol ID: HIC140101333
Status last verified: Sep 2016
First submitted: 19 May 2014
Last updated: 4 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT02145299
Acronym / sponsor ID: HIC140101333
Conditions: Symptomatic Femoro-popliteal Chronic Total Occlusion
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was stopped due to insufficient numbers of subjects to meet study design objectives.
Enrolment: 8 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: Boston Scientific Corporation
Study start: May 2014
Primary completion: Mar 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 22 May 2014 (estimated)
Results: Posted 4 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
TruePath CTO Device	Experimental	Device: TruePath CTO DeviceThe 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	Device: CROSSER CTO DeviceThe 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.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TruePath CTO DeviceThe 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.	Device	TruePath CTO Device
CROSSER CTO Device	Device	CROSSER CTO Device

Primary outcome

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
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)

9 secondary outcomes

Procedural Success
Time frame: Day of operation
Clinical Success
Time frame: Day of operation
Symptomatic Improvement
Time frame: Baseline, and 30 days post operation
Walking Capacity
Time frame: Baseline and 30 days post operation
Index Limb Amputation
Time frame: Day of Operation through 30 days post operation
Target Lesion Revascularization
Time frame: 30 days post operation
Ankle-brachial Index (ABI)
Time frame: baseline to 30 days post operation
Target Vessel Revascularization
Time frame: 30 days post operation
Angiographic Perforation Classification and Rate
Time frame: Day of operation

Results and safety

Results posted to the registry on 4 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TruePath CTO Device	6	6
CROSSER CTO Device	2	2

Primary outcome: Technical Success

Time frame: Day of operation. Number. Unit: percentage of participants

Measure	TruePath CTO Device n = 6	CROSSER CTO Device n = 2
Value	50	0

Primary outcome: In-hospital Safety

Time frame: Operation through 30 day follow up. Number. Unit: percentage of participants

Measure	TruePath CTO Device n = 6	CROSSER CTO Device n = 2
Value	0	0

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TruePath CTO Device	0 of 6 (0%)	0 of 6 (0%)	Not reported
CROSSER CTO Device	0 of 2 (0%)	0 of 2 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carlos Mena, MD principal investigator

Yale University

Alexandra Lansky, MD principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TruePath CTO Device and CROSSER CTO Device in people with Symptomatic Femoro-popliteal Chronic Total Occlusion, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Technical Success (time frame: Day of operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02145299.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2016.