Peripheral Artery DiseaseNCT03013088

Soundbite Crossing System Peripheral First in Man

A study testing CTO Crossing in people with Peripheral Artery Disease, run by SoundBite Medical Solutions, Inc. at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a clinical study aimed at demonstrating the safety and product performance of the SoundBite Crossing System. The study shall demonstrate that the SoundBite Crossing System can facilitate passage of a standard guidewire through a Chronic Total Occlusion (CTO) located in the lower extremity arteries without… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Artery Disease
What is being tested?: CTO Crossing
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 2 sitesCanada
Study dates: Dec 2016to Sep 2017
Phase: Interventional
Are there results?: None posted in the registry

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Symptomatic target leg ischemia, requiring treatment of an infrainguinal artery.
Rutherford Category of 2-5.
≥ 18 years of age.
Life expectancy > 1 year.
Able and willing to provide written informed consent prior to study procedure.
Evidence that the target CTO lesion is a de novo or restenotic chronic total occlusion in the SFA (starting at least 1cm distal to the origin of the SFA) and/or popliteal artery (ending at least 1cm proximal to the popliteal trifurcation), confirmed by angiography; AND/OR Evidence that the target CTO lesion is a de novo or restenotic chronic total occlusion and is located below the popliteal trifurcation in the anterior tibial, posterior tibial or peroneal arteries (at least 1 cm distal to the vessel origin, and ending at least 1cm proximal to the dorsalis pedis or plantar arteries), confirmed by angiography.

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Target CTO lesion is 100% occluded by visual estimate.
Target limb has at least one patent (<50% stenosis) tibio-peroneal run-off vessel to the foot confirmed by baseline angiography or magnetic resonance angiography (MRA) or computed tomography angiography (CTA).
Target CTO lesion has a cumulative lesion length of no more than 40 cm and terminates at least 1 cm above the ankle or tibio-talar joint.
Reference vessel diameter, by visual estimate, is ≥ 4 mm for femoral-popliteal arteries, or ≥ 2 mm for tibial or peroneal arteries.

Who cannot join

History of previous peripheral bypass or stent placement, affecting the target CTO lesion (i.e. target CTO lesion (de novo or restenotic) must be at least 1cm proximal or distal to a surgical bypass graft anastomosis or stent edge to be eligible for treatment).
History of receiving a kidney transplant.
Current significant acute or chronic kidney disease with a creatinine level > 220 micromoles/Land/or requiring dialysis.
Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb.
History of an endovascular procedure or open vascular surgery on the index limb within the 30 days prior to enrollment.
Any planned surgical or interventional procedure within 30 days after the index procedure.

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Unstable coronary artery disease or other uncontrolled comorbidity.
Myocardial infarction or stroke within 3 months prior to enrollment.
Currently pregnant or breast-feeding.
Participating in any study of an investigational device, medication, biologic, or other agent within 30 days prior to enrollment that is either a cardiovascular study or could, in the judgement of the Investigator, affect the results of this study.
Known significant stenosis or occlusion of inflow tract (upstream disease) not successfully treated before index procedure.
Contraindication to antiplatelet medications, anticoagulant medication, or thrombolytic therapy.
Current uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, known coagulopathy, or INR >1.5.
Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
History of heparin-induced thrombocytopenia (HIT).
Received thrombolytic therapy within two weeks of enrollment.
Known psychiatric disorder which in the judgement of the Investigator could interfere with provision of informed consent, completion of tests, therapy, or follow-up.
Clinical/angiographic complication (other than non-flow limiting dissections) attributed to a currently marketed device prior to introduction of SoundBite Crossing System.
Acute or sub-acute intraluminal thrombus within the target vessel.
Aneurysm (at least twice the reference vessel diameter) located in the target vessel or popliteal artery.
Perforation, dissection or other injury of the access or target vessel requiring stenting or surgical intervention.
Clinical/angiographic evidence of distal embolization in the target limb.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

CHUM - Centre Hospitalier de l'Université de Montreal - Hôtel-Dieu
Montreal, Quebec, H2W 1T8
CHUS - Centre Hospitalier Universitaire de Sherbrooke - Freurimont
Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

About this study

Official title: A First in Man Study to Assess the Soundbite Crossing System When Used to Cross Infrainguinal Chronic Total Occlusions

Read the detailed description

Prospective, multi-center, single-arm, two-phase clinical study. This study will be conducted in two phases.

The first phase will consist of ten (10) subjects enrolled and treated using the SoundBite Crossing System with 30 day follow-up. An analysis shall be performed after 10 subjects undergo treatment with the SoundBite Crossing System and complete 30 day follow-up. This analysis shall be utilized to provide insight into product performance and safety.

The second phase will consist of up to forty (40) subjects enrolled and treated using the SoundBite Crossing System with 30 day follow-up. An analysis will be generated on this subject cohort after 30 day follow-up is complete.

Conditions: Peripheral Artery Disease
Being tested: CTO Crossing
Keywords: Chronic, Occlusion, CTO
Medical subject headings: Peripheral Arterial Disease, Bronchiolitis Obliterans Syndrome, Bites and Stings

What participants receive

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

CTO CrossingDevice
With confirmation that the target vessel is completely occluded by the target CTO lesion, the operator shall initially attempt crossing the proximal end of the target CTO lesion by advancing ShockWireTM device ≥ 1cm. The SoundBite Crossing device can be activated as needed to perform the procedure and may be used for the entire length of the lesion(s).

Study groups in NCT03013088
Study group	Role	What they receive
CTO Crossing	Experimental	With confirmation that the target vessel is completely occluded by the target CTO lesion, the operator shall initially attempt crossing the proximal end of the target CTO lesion by advancing ShockWireTM device ≥ 1cm. The SoundBite Crossing device can be activated as needed to perform the procedure and may be used for the entire length of the lesion(s). Receives: Device: CTO Crossing

What is being measured

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

Device Success
Device Success is the primary endpoint for the study. Device Success is defined as the achievement of Technical Success with freedom from Major Adverse Events through 30 day follow-up, per Independent Physician Reviewer (IPR) adjudication.
Measured: 30 Day follow-up

Secondary outcomes (1)

Technical Success
Technical Success: the ability of the SoundBite Crossing System to facilitate crossing of a target CTO lesion, defined as: The ShockWireTM being advanced by 1cm or more into proximal aspect of target CTO lesion based on angiography; AND Either the ShockWireTM or other commercially available device (e.g. guidewire) is able to cross target CTO lesion.
Technical Success shall be assessed at the time of the index procedure after all ShockWireTM devices have been used on the target CTO lesion (if more than one ShockWireTM device was utilized to address the target CTO lesion).
Measured: At the time of the index procedure

Timeline

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

Dec 2016Sep 2017

First posted6 Jan 2017 (estimated)
Study startDec 2016
Primary completionSep 2017
Study completionSep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
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 N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03013088
Sponsor's protocol ID: CP-PER-2015-01
Status last verified: Nov 2017
First submitted: 4 Jan 2017
Last updated: 17 Nov 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
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Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
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All Peripheral Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A First in Man Study to Assess the Soundbite Crossing System When Used to Cross Infrainguinal Chronic Total Occlusions
ClinicalTrials.gov ID: NCT03013088
Acronym / sponsor ID: CP-PER-2015-01
Conditions: Peripheral Artery Disease
Keywords: Chronic, Occlusion, CTO
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: SoundBite Medical Solutions, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2016 (actual)
Primary completion: Sep 2017 (actual)
Study completion: Sep 2017 (actual)
First posted: 6 Jan 2017 (estimated)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Prospective, multi-center, single-arm, two-phase clinical study. This study will be conducted in two phases.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CTO Crossing	Experimental	Device: CTO CrossingWith confirmation that the target vessel is completely occluded by the target CTO lesion, the operator shall initially attempt crossing the proximal end of the target CTO lesion by advancing ShockWireTM device ≥ 1cm. The SoundBite Crossing device can be activated as needed to perform the procedure and may be used for the entire length of the lesion(s).

Who may qualify

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

Key inclusion criteria (10 listed)

Symptomatic target leg ischemia, requiring treatment of an infrainguinal artery.
Rutherford Category of 2-5.
≥ 18 years of age.
Life expectancy > 1 year.
Able and willing to provide written informed consent prior to study procedure.

Key exclusion criteria (22 listed)

History of previous peripheral bypass or stent placement, affecting the target CTO lesion (i.e. target CTO lesion (de novo or restenotic) must be at least 1cm proximal or distal to a surgical bypass graft anastomosis or stent edge to be eligible for treatment).
History of receiving a kidney transplant.
Current significant acute or chronic kidney disease with a creatinine level > 220 micromoles/Land/or requiring dialysis.
Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb.
History of an endovascular procedure or open vascular surgery on the index limb within the 30 days prior to enrollment.

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
CTO CrossingWith confirmation that the target vessel is completely occluded by the target CTO lesion, the operator shall initially attempt crossing the proximal end of the target CTO lesion by advancing ShockWireTM device ≥ 1cm. The SoundBite Crossing device can be activated as needed to perform the procedure and may be used for the entire length of the lesion(s).	Device	CTO Crossing

Primary outcome

Device Success
Time frame: 30 Day follow-up
Device Success is the primary endpoint for the study. Device Success is defined as the achievement of Technical Success with freedom from Major Adverse Events through 30 day follow-up, per Independent Physician Reviewer (IPR) adjudication.

1 secondary outcome

Technical Success
Time frame: At the time of the index procedure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
Individual participant dataSharing planned: No

Related trials for Peripheral Artery Disease

RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Preventing Kidney Injury Using Carbon Dioxide as Contrast Medium in Patients With Peripheral Arterial Disease (PAD) and Chronic Kidney Disease (CKD) Having Arterial Intervention
Peripheral Arterial Disease, Chronic Kidney Diseases
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
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RecruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingObservational study
Aspiration Thrombectomy Using the Symphony or Prodigy System
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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.

Andrew Benko, MD principal investigator

CHUS - Centre Hospitalier Universitaire de Sherbrooke - Fleurimont

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

Questions about this trial

What is this clinical trial studying?

A study testing CTO Crossing in people with Peripheral Artery Disease, run by SoundBite Medical Solutions, Inc. at 2 sites in Canada.

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 10 inclusion and 22 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: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Device Success (time frame: 30 Day follow-up). 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 NCT03013088.

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 17 Nov 2017.