SoundBite™ Crossing System Pivotal Peripheral CTO Crossing Study (PROSPECTOR)

April 24, 2019 updated by: SoundBite Medical Solutions, Inc.

A Multinational, Single-Arm Pivotal Study to Assess the Performance Rate Of SoundBite™ Active Wire for PEripheral Chronic Total Occlusion Recanalization (PROSPECTOR)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a multinational, single-arm, pivotal trial assessing the efficacy and safety of the SoundBite™ Crossing System - Peripheral. The enrollment will consist of up to 100 patients meeting the inclusion/exclusion criteria in order to obtain 90 evaluable patients for efficacy and safety analysis. The primary endpoints will be compared to literature-based performance goals to establish study success.

Objective Performance Goals (OPG) have been obtained from a literature based review. Reports published in the past 10 years were reviewed for both safety and effectiveness in crossing infrainguinal CTO. The studies reviewed generally have one primary composite safety endpoint and one primary efficacy endpoint. Some studies have performed formal hypothesis testing versus a pre-specified performance goal for one or both endpoints.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H2W 1T8
        • CHUM-Hôtel-Dieu du Centre Hospitalier Universitaire de Montréal
  • United States
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • UNC Rex Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

General Inclusion Criteria:

  1. Has symptomatic chronic limb ischemia, requiring treatment of an in:frainguinal artery
  2. Has Rutherford Clinical Category of 2-5
  3. Is ≥ 18 years old
  4. Has life expectancy > 1 year
  5. Is able and willing to provide written informed consent prior to study procedure

Angiographic Inclusion Criteria:

Unless otherwise specified, the Investigator performing the procedure bases angiographic inclusion on visual determination of qualification imaging taken at time of procedure.

Subject must meet ALL the following angiographic inclusion criteria:

  1. 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.
  2. 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.
  3. 100% stenosis by visual estimate of angiography at time of procedure.
  4. Has target limb with at least one patent (<50% stenosis) run-off vessel confirmed by angiography or magnetic resonance angiography at time of procedure.

General Exclusion Criteria:

  1. Has had a previous peripheral bypass that includes the target vessel.
  2. Has had a previous intervention on the target CTO (e.g., angioplasty, stent placement), including previous attempt at time of index procedure.
  3. History of any vascular procedure on the index limb within the last 30 days requiring clinically driven re-intervention.
  4. Has an active infection in the target limb.
  5. Subject has any planned major surgical or interventional procedure within 30 days after the study procedure.
  6. Has received a kidney transplant.
  7. Glomerular Filtration Rate (GFR) of less than 40.
  8. Unstable coronary artery disease or other uncontrolled comorbidity.
  9. Myocardial infarction or stroke within 2 months prior to baseline evaluation.
  10. Subject has positive pregnancy test result in women of child bearing potential or is breast-feeding.
  11. 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.
  12. Subject in whom antiplatelet, anticoagulant therapy is contraindicated
  13. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/ml or known coagulopathy.
  14. 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.
  15. History of heparin-induced thrombocytopenia (HIT) that cannot be treated with direct thrombin inhibitors.
  16. Any thrombolytic therapy within two weeks prior to enrollment.

  17. Psychiatric disorder which in the judgment of the investigator could interfere with provision of informed consent, completion of tests, therapy, follow-up or general study compliance

    Angiographic Exclusion Criteria

    Unless otherwise specified, the Investigator performing the procedure bases angiographic exclusion on visual determination of qualification imaging taken up to 6 months prior to procedure and/or imaging taken at time of procedure. Subject is excluded if ANY of the following angiographic exclusion criteria is met:

  18. Has significant stenos is or occlusion of inflow tract ( upstream disease) unsuccessfully treated at time of index procedure or presenting symptoms such as embolism confirmed by angiography.
  19. Has in a native vessel, a previously stented segment separated by < 3 cm of angiographically normal vessel from the target CTO.
  20. CTOs lacking at least one patent target distal artery (::;SO% diameter stenosis).
  21. Has an acute or sub-acute intraluminal thrombus within the target vessel.
  22. Aneurysm distal to puncture access site at least twice the reference vessel diameter, located in the index vessel, abdominal aorta, iliac or popliteal.
  23. Has perforation, dissection or other injury of the access site or index vessel requiring stenting or surgical intervention prior attempting crossing of the target lesion with SoundBite™ Crossing System.
  24. Clinical/angiographic evidence of distal embolization in the index extremity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: SoundBite™ Crossing System - Peripheral
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
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Technical Device Success
Time Frame: Day 1
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
Time Frame: up to Day 30

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedural success
Time Frame: Day 1
Achievement of Technical Success together with post-procedural patency. Post-procedural patency is defined as less then or equal to 50% residual percent diameter stenosis assessed by visual estimate at the end of revascularization procedure
Day 1
Clinical Success
Time Frame: Up to Day 30
Achievement of Procedural Success as well as freedom from SoundBite™ Crossing System related MAEs at 30 days
Up to Day 30
Penetration ≥ 0.5 cm
Time Frame: Day 1
Ability of the SoundBite™ Crossing System to penetrate ≥ 0.5 cm of any segment of the CTO
Day 1
Fully traverse
Time Frame: Day 1
Ability of the SoundBite™ Crossing System to fully traverse the CTO with entry into the distal true lumen without the need for additional guidewires and/or re-entry devices
Day 1
Freedom from any SoundBite™ Crossing System related Adverse Events
Time Frame: Up to Day 30
Freedom from any SoundBite™ Crossing System related Adverse Events
Up to Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SoundBite Medical Solutions, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ethica Clinical Research Inc.
Prairie Vascular Research Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 18, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 18, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NAP-PER-2017-01

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

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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