Prospective Study of the SoundBite™ Crossing System in Complex Peripheral CTOs

NCT03933657 | Withdrawn DMC

• 1 other identifier: INT-PER-2019-01
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

Brief Summary

This study aims at assessing additional performance characteristics of the SoundBite™ Crossing System with regards to the luminal passage of complex Chronic Total Occlusions (CTO) by evaluating clinically relevant efficacy, safety, cost benefit and treatment pathway endpoints.

Conditions

Peripheral Arterial Occlusive Disease; Chronic Total Occlusion of Artery of the Extremities

Keywords

Chronic Total Occlusion; CTO; Crossing Device; Peripheral; SoundBite Crossing System

Outcome Measures

Primary Outcomes (1)

• Successful CTO Crossing assessed by angiographic imaging

  Successful CTO Crossing using the SoundBite™ Crossing System (SCS)

  at time of procedure

Secondary Outcomes (3)

• Successful luminal CTO crossing using the SCS with or without imaging assistance.

  at time of procedure

• Costs benefits associated with the use of the SCS compared to a retrospective randomly selected chart review of conventional PTA wire escalation at the clinical site.

  through study completion; 15 months

• Freedom from SCS related Major Adverse Events (MAE) at the time of procedure/discharge

  at procedure until discharge; up to 48 hours

Study Arms (1)

SoundBite™ Crossing System - Peripheral

EXPERIMENTAL

SoundBite™ Crossing System-Peripheral is indicated to facilitate the intraluminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions via atherectomy.

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 non-acute limb ischemia, requiring treatment of an infrainguinal artery
• Has Rutherford Clinical Category of 2-6
• is able and willing to provide written informed consent prior to study procedure
• % stenosis by a visual estimate of angiography at the time of the procedure
• target CTO has moderate to severe calcification
• Has at least one of the following: severe calcification, flush occlusion, femoropopliteal CTOs with reconstitution below Popliteal 2-3, side directing collateral at the proximal cap, long (≥ 5cm) occlusions, below the knee (BTK) occlusion.
• Has evidence of a clinically significant CTO located in a peripheral vessel below the infrainguinal ligament confirmed by angiography at time of the procedure.

You may not qualify if:

• Insufficient kidney function or renal failure
• Subject has positive pregnancy test result
• Participation in any study of a study 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.
• Psychiatric disorder which in the judgment of the investigator could interfere with provision of informed consent, completion of tests, therapy or general study compliance.
• The target CTO is located \< 3 cm from a stented segment.
• Has an acute or sub-acute intraluminal thrombus within the target vessel.
• Clinical/ angiographic evidence of distal embolization in the index extremity unresolved prior to crossing.

Sponsors & Collaborators

• SoundBite Medical Solutions, Inc.: lead
• ethica Clinical Research Inc.: collaborator
• Montreal Heart Institute: collaborator

Study Sites (2)

Medical University of Graz

Graz, 8036, Austria

Location

Klinikum Hochsauerland GmbH, Klinik für Angiologie

Arnsberg, 59759, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Study Officials

• George Adams, MD

  Rex Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: The population includes subjects with documented symptomatic peripheral CTOs.

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 1, 2019
• Study Start: December 30, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); DE (1)