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

NCT ID: NCT03933657

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-30
• Study Completion Date: 2023-09-30

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.

Detailed Description

This multinational study will be based on observational cases with descriptive statistics to collect data on safety and efficacy based on clinical use of the SoundBite™ Crossing System.

This study will include a cost benefit analysis that will focus on wire and other Percutaneous Transluminal Angioplasty (PTA) device usage during the procedure. The cost benefit will be compared to the sites data on their average costs for CTO crossing cases.

The planned treatment pathway elected prior to procedure will be compared to subject's treatment pathway plan post -procedure (discharge, surgeries such as bypass, amputation etc.) will be collected to determine patient outcomes.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SoundBite™ Crossing System - Peripheral

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.

Group Type: EXPERIMENTAL

SoundBite™ Crossing System - Peripheral

Intervention Type: 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.

Interventions

SoundBite™ Crossing System - Peripheral

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 100% 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ethica Clinical Research Inc.

INDUSTRY

Sponsor Role: collaborator

Montreal Heart Institute

OTHER

Sponsor Role: collaborator

SoundBite Medical Solutions, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Adams, MD

Role: PRINCIPAL_INVESTIGATOR

Rex Hospital

Locations

Medical University of Graz

Graz, , Austria

Klinikum Hochsauerland GmbH, Klinik für Angiologie

Arnsberg, , Germany

Countries

Austria; Germany

Other Identifiers

INT-PER-2019-01

Identifier Type: -

Identifier Source: org_study_id