SoundBite™ Crossing System Pivotal Peripheral CTO Crossing Study

NCT03266835 | Completed DMC FDA Device

• 1 other identifier: NAP-PER-2017-01
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 2

Brief Summary

This study is aimed at demonstrating the efficacy and safety of the SoundBite™ Crossing System-Peripheral. The study is intended to demonstrate that the SoundBite™ Crossing System can facilitate the passage of either devices intended to treat a chronic total occlusion (CTO) or additional crossing devices through an infrainguinal CTO into the true lumen.

Conditions

Chronic Total Occlusion of Arteries of the Extremities

Keywords

Chronic Total Occlusion; Peripheral; SoundBite™ Crossing System; CTO; intra-luminal; Active wire; Device; Procedure

Outcome Measures

Primary Outcomes (2)

• Technical Device Success

  Ability to facilitate treatment of the target lesion by allowing additional crossing and/or treatment devices to cross the CTO

  Day 1

• Freedom from SoundBite™ Crossing System related MAEs at 30 days post procedure

  MAEs defined as: * Cardiovascular related deaths * Unplanned, index limb amputation * Dissection of grade C or greater that require an intervention to resolve * Symptomatic distal embolization, defined as clinical signs or symptoms of distal emboli detected in the treated limb distal to the treated lesion after the index procedure or noted angiographically after the index procedure, and requiring mechanical or pharmacologic means to improve flow

  up to Day 30

Secondary Outcomes (5)

• Procedural success

  Day 1

• Clinical Success

  Up to Day 30

• Penetration ≥ 0.5 cm

  Day 1

• Fully traverse

  Day 1

• Freedom from any SoundBite™ Crossing System related Adverse Events

  Up to Day 30

Study Arms (1)

SoundBite™ Crossing System - Peripheral

OTHER

This is a multinational, single-arm, pivotal trial assessing the efficacy and safety of the SoundBite™ Crossing System with subjects diagnosed with de novo infrainguinal arterial chronic total occlusion(s).

Device: SoundBite™ Crossing System - Peripheral

Interventions

SoundBite™ Crossing System - Peripheral DEVICE

SoundBite™ Crossing System consisting of the SoundBite™ Console and SoundBite™ Active Wire 18. The Investigator may use the SoundBite™ Active Wire during the procedure to cross the proximal aspect and/or to cross multiple lesions.

SoundBite™ Crossing System - Peripheral

Eligibility Criteria

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

You may qualify if:

• Has symptomatic chronic limb ischemia, requiring treatment of an in:frainguinal artery
• Has Rutherford Clinical Category of 2-5
• Is ≥ 18 years old
• Has life expectancy \> 1 year
• Is able and willing to provide written informed consent prior to study procedure
• Has evidence of a clinically significant de novo CTO located in a peripheral vessel below the infrainguinal ligament confirmed by angiography at time of procedure.
• Notwithstanding criteria 1, multilevel CTOs are included as long as the total length from the beginning of the most proximal total occlusion to the end of the most distal total occlusion is less than 40 cm.
• % stenosis by visual estimate of angiography at time of procedure.
• Has target limb with at least one patent (\<50% stenosis) run-off vessel confirmed by angiography or magnetic resonance angiography at time of procedure.

You may not qualify if:

• Has had a previous peripheral bypass that includes the target vessel.
• Has had a previous intervention on the target CTO (e.g., angioplasty, stent placement), including previous attempt at time of index procedure.
• History of any vascular procedure on the index limb within the last 30 days requiring clinically driven re-intervention.
• Has an active infection in the target limb.
• Subject has any planned major surgical or interventional procedure within 30 days after the study procedure.
• Has received a kidney transplant.
• Glomerular Filtration Rate (GFR) of less than 40.
• Unstable coronary artery disease or other uncontrolled comorbidity.
• Myocardial infarction or stroke within 2 months prior to baseline evaluation.
• Subject has positive pregnancy test result in women of child bearing potential or is breast-feeding.
• Participation in any study of an investigational device, medication, biologic, or other agent during study or within 30 days prior to enrollment that is either a cardiovascular study or could, in the judgment of the investigator, affect the results of this study.
• Subject in whom antiplatelet, anticoagulant therapy is contraindicated
• Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/ml or known coagulopathy.
• Known, untreated allergy to contrast agents or medications used during or subsequent to endovascular intervention. Patients with aspirin allergy that have been desensitized are not excluded.
• History of heparin-induced thrombocytopenia (HIT) that cannot be treated with direct thrombin inhibitors.

Sponsors & Collaborators

• SoundBite Medical Solutions, Inc.: lead
• ethica Clinical Research Inc.: collaborator
• Prairie Vascular Research Inc.: collaborator

Study Sites (2)

UNC Rex Healthcare

Raleigh, North Carolina, 27607, United States

Location

CHUM-Hôtel-Dieu du Centre Hospitalier Universitaire de Montréal

Montreal, Quebec, H2W 1T8, Canada

Location

Study Design

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

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: August 30, 2017
• Study Start: November 16, 2017
• Primary Completion: January 18, 2019
• Study Completion: January 18, 2019
• Last Updated: April 25, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (1)