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

Prospective Study on the Clinical Effectiveness, Safety, Cost Benefits, and Outcomes of the SoundBite™ Crossing System in Complex Peripheral CTOs - The PROSPECTOR II Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Peripheral Arterial Occlusive Disease; Chronic Total Occlusion of Artery of the Extremities
• Intervention / Treatment: Device: SoundBite™ Crossing System - Peripheral

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Customer Service; Phone Number: (514) 312-9181; Email: customerservice@soundbitemedical.com
• Study Contact Backup: Name: Safety; Phone Number: (514) 312-9181; Email: safety@soundbitemedical.com

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medical University of Graz
    • Contact: Gabriele Platzer; Email: Gabriele.Platzer@klinikum-graz.at
    • Contact: Marianne Brodmann, MD; Phone Number: +43/316/38580286; Email: marianne.brodmann@medunigraz.at
    • Principal Investigator: Marianne Brodmann, MD
• Germany
  • Arnsberg, Germany, 59759
    • Klinikum Hochsauerland GmbH, Klinik für Angiologie
    • Contact: Simone Müller; Phone Number: +49 (0) 2932 952-244823; Email: S.Mueller@klinikum-hochsauerland.de
    • Contact: Michael Lichtenberg, MD; Phone Number: +49 (0) 2932 952242201; Email: klichte@gmx.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

General 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

Angiographic Inclusion Criteria

• 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:

General 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.

Angiographic Exclusion Criteria

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful CTO Crossing assessed by angiographic imaging	Successful CTO Crossing using the SoundBite™ Crossing System (SCS)	at time of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful luminal CTO crossing using the SCS with or without imaging assistance.	Luminal crossing defined as ≥50% true lumen passage as assessed by an independent imaging core lab.	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.	Imaging costs are excluded	through study completion; 15 months
Freedom from SCS related Major Adverse Events (MAE) at the time of procedure/discharge	MAEs examples: unplanned, index limb amputation, dissection of grade C or greater that require an intervention to resolve	at procedure until discharge; up to 48 hours

Collaborators and Investigators

• Sponsor: SoundBite Medical Solutions, Inc.
• Collaborators: Montreal Heart Institute; ethica Clinical Research Inc.
• Investigators: Principal Investigator: George Adams, MD, Rex Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2022
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): September 30, 2023

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Total Occlusion; Peripheral; CTO; Crossing Device; SoundBite Crossing System
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: INT-PER-2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No