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

Primary Purpose

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

Status

Withdrawn

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

SoundBite™ Crossing System - Peripheral

About this trial

This is an interventional treatment trial for Peripheral Arterial Occlusive Disease focused on measuring Chronic Total Occlusion, CTO, Crossing Device, Peripheral, SoundBite Crossing System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Medical University of Graz
Klinikum Hochsauerland GmbH, Klinik für Angiologie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SoundBite™ Crossing System - Peripheral

Arm Description

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.

Outcomes

Primary Outcome Measures

Successful CTO Crossing assessed by angiographic imaging

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

Secondary Outcome Measures

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.

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

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

Full Information

NCT ID

NCT03933657

First Posted

April 24, 2019

Last Updated

September 12, 2023

Sponsor

SoundBite Medical Solutions, Inc.

Collaborators

ethica Clinical Research Inc., Montreal Heart Institute

1. Study Identification

Unique Protocol Identification Number

NCT03933657

Brief Title

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

Acronym

PROSPECTORII

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Replaced by CaTO-PAD/BTK Study

Study Start Date

December 30, 2022 (Anticipated)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SoundBite Medical Solutions, Inc.

Collaborators

ethica Clinical Research Inc., Montreal Heart Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

The population includes subjects with documented symptomatic peripheral CTOs.

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SoundBite™ Crossing System - Peripheral

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

SoundBite™ Crossing System - Peripheral

Intervention Description

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.

Primary Outcome Measure Information:

Title

Successful CTO Crossing assessed by angiographic imaging

Description

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

Time Frame

at time of procedure

Secondary Outcome Measure Information:

Title

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

Description

Luminal crossing defined as ≥50% true lumen passage as assessed by an independent imaging core lab.

Time Frame

at time of procedure

Title

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.

Description

Imaging costs are excluded

Time Frame

through study completion; 15 months

Title

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

Description

MAEs examples: unplanned, index limb amputation, dissection of grade C or greater that require an intervention to resolve

Time Frame

at procedure until discharge; up to 48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

George Adams, MD

Organizational Affiliation

Rex Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of Graz

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Klinikum Hochsauerland GmbH, Klinik für Angiologie

City

Arnsberg

ZIP/Postal Code

59759

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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