Soundbite Crossing System Peripheral First in Man

NCT03013088 | Completed

• 1 other identifier: CP-PER-2015-01
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief 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 major adverse events related to SoundBite device utilization.

Conditions

Peripheral Artery Disease

Keywords

Chronic; Occlusion; CTO

Outcome Measures

Primary Outcomes (1)

• 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.

  30 Day follow-up

Secondary Outcomes (1)

• Technical Success

  At the time of the index procedure

Study Arms (1)

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).

Device: CTO Crossing

Interventions

CTO Crossing DEVICE

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).

CTO Crossing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• SoundBite Medical Solutions, Inc.: lead

Study Sites (2)

CHUM - Centre Hospitalier de l'Université de Montreal - Hôtel-Dieu

Montreal, Quebec, H2W 1T8, Canada

Location

CHUS - Centre Hospitalier Universitaire de Sherbrooke - Freurimont

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Bronchiolitis Obliterans Syndrome; Bites and Stings

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Andrew Benko, MD

  CHUS - Centre Hospitalier Universitaire de Sherbrooke - Fleurimont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 6, 2017
• Study Start: December 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)