Peripheral Arterial Occlusive DiseasePROSPECTORIINCT03933657
Prospective Study of the SoundBite™ Crossing System in Complex Peripheral CTOs
A study testing SoundBite™ Crossing System - Peripheral in people with Peripheral Arterial Occlusive Disease and Chronic Total Occlusion of Artery of the Extremities, run by SoundBite Medical Solutions, Inc. at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Occlusive Disease, Chronic Total Occlusion of Artery of the Extremities
- What is being tested?
- SoundBite™ Crossing System - Peripheral
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Dec 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Klinikum Hochsauerland GmbH, Klinik für Angiologie
Arnsberg, 59759
About this study
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
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.
Read the 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
- Being tested
- SoundBite™ Crossing System - Peripheral
- Keywords
- Chronic Total Occlusion, CTO, Crossing Device, Peripheral, SoundBite Crossing System
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoundBite™ Crossing System - PeripheralDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SoundBite™ Crossing System - Peripheral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful CTO Crossing assessed by angiographic imaging
Successful CTO Crossing using the SoundBite™ Crossing System (SCS)
Measured: at time of procedure
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: at procedure until discharge; up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start30 Dec 2022 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Why it stopped: Replaced by CaTO-PAD/BTK Study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Occlusive DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The population includes subjects with documented symptomatic peripheral CTOs.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- SoundBite Medical Solutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc., Montreal Heart Institute
- Responsible party
- Sponsor
- Investigators
- George Adams, MD, Principal investigator, Rex Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933657
- Sponsor's protocol ID
- INT-PER-2019-01
- Acronym
- PROSPECTORII
- Status last verified
- Sep 2023
- First submitted
- 24 Apr 2019
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03933657
- Acronym / sponsor ID
- PROSPECTORII / INT-PER-2019-01
- Conditions
- Peripheral Arterial Occlusive Disease, Chronic Total Occlusion of Artery of the Extremities
- Keywords
- Chronic Total Occlusion, CTO, Crossing Device, Peripheral, SoundBite Crossing System
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Replaced by CaTO-PAD/BTK Study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SoundBite Medical Solutions, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ethica Clinical Research Inc., Montreal Heart Institute
- Study start
- 30 Dec 2022 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The population includes subjects with documented symptomatic peripheral CTOs.
| Arm | Type | Receives |
|---|---|---|
| SoundBite™ Crossing System - Peripheral | Experimental | Device: SoundBite™ Crossing System - PeripheralSoundBite™ Crossing System-Peripheral is indicated to facilitate the intraluminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions via atherectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SoundBite™ Crossing System - PeripheralSoundBite™ 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. | Device | SoundBite™ Crossing System - Peripheral |
Primary outcome
Successful CTO Crossing assessed by angiographic imaging
Time frame: at time of procedure
Successful CTO Crossing using the SoundBite™ Crossing System (SCS)
3 secondary outcomes
Successful luminal CTO crossing using the SCS with or without imaging assistance.
Time frame: 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.
Time frame: through study completion; 15 months
Freedom from SCS related Major Adverse Events (MAE) at the time of procedure/discharge
Time frame: at procedure until discharge; up to 48 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Adams, MD principal investigator
Rex Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SoundBite™ Crossing System - Peripheral in people with Peripheral Arterial Occlusive Disease and Chronic Total Occlusion of Artery of the Extremities, run by SoundBite Medical Solutions, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful CTO Crossing assessed by angiographic imaging (time frame: at time of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.