Safety and Efficacy Study of the SoundBite™ Crossing System With ACTIVE Wire in Coronary CTOs.
NCT ID: NCT03521804
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
35 participants
INTERVENTIONAL
2018-06-21
2020-11-20
Brief Summary
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Detailed Description
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SoundBite™ Crossing System - Coronary, which consists of a re-usable console and a disposable device (ACTIVE Wire).
The SoundBite™ Crossing System - Coronary is intended to facilitate passage of a guidewire or therapeutic devices through a coronary artery Chronic Total Occlusion.
This is a prospective, multi-center, multinational, single-arm, phased clinical study intended to provide pivotal data for device approval.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SoundBite™ Crossing System-Coronary
Crossing of coronary chronic total occlusions.
SoundBite™ Crossing System Active Wire 14
Successful crossing of the CTO into the true arterial lumen distal to the occlusion, following use of the SoundBite™ Crossing Wire during the procedure and using antegrade only approach. An antegrade only approach may involve Antegrade Dissection Re-Entry (ADR) with or without the use of specialized devices (i.e. Stingray). The absence of successful retrograde crossing of a collateral will still be considered an antegrade only approach.
Interventions
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SoundBite™ Crossing System Active Wire 14
Successful crossing of the CTO into the true arterial lumen distal to the occlusion, following use of the SoundBite™ Crossing Wire during the procedure and using antegrade only approach. An antegrade only approach may involve Antegrade Dissection Re-Entry (ADR) with or without the use of specialized devices (i.e. Stingray). The absence of successful retrograde crossing of a collateral will still be considered an antegrade only approach.
Eligibility Criteria
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Inclusion Criteria
2. PCI procedure is planned to be performed with a wire based antegrade primary strategy.
3. Subject is ≥ 18 years old.
4. Subject is able and willing to provide written informed consent prior to study procedure.
1. Target CTO is in a native coronary artery and demonstrates TIMI flow grade 0.
2. Target CTO is presumed documented angiographically to be greater than 3 months old.
3. Target CTO length is visually estimated to be ≥ 5mm.
4. Target reference vessel diameter ≥ 2.5mm.
5. Target CTO shows calcification.
6. Target CTO has a positive tap test, which correspond to the inability to penetrate the cap by visual estimate using a polymer-jacketed or enhanced tip stiffness (\>1.5 gm) coronary guidewire manipulated with the intention to cross the occlusion for at least 60 seconds of fluoroscopy time after initial guidewire-cap contact. The tap test is intended to confirm the chronicity of the lesion and rule out acute or sub-acute occlusions that will likely be crossed with such simple wire maneuvers.
1. Target CTO is in an unprotected left main.
2. No angiographically visible collateral flow to the target vessel distal to the occlusion, from ipsilateral or contralateral collaterals.
3. Vessel tortuosity proximal to, or within, body of target occlusion which, in the opinion of the investigator, is not amenable to advancement of a microcatheter or SoundBite™ Crossing System
Exclusion Criteria
2. Hypersensitivity or contraindication to aspirin, P2Y12 platelet receptor inhibitors, heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available.
3. Target occlusion has an iatrogenic dissection that occurred within the past 3 months.
4. Subject has received ≥5 Gy exposure to the chest within 3 months.
5. Subject has known elevated cardiac biomarkers (CK-MB or cTn) within 30 days prior to index procedure.
6. Left ventricular ejection fraction less than 20%.
7. Severe aortic or mitral valve disease.
8. Planned left ventricular (LV) support device during CTO PCI.
9. History of bleeding diatheses, coagulopathy.
10. Recent (within 6 months prior to index procedure) stroke or transient ischemic attack (TIA).
11. Recent (within 6 months prior to index procedure) significant gastrointestinal (GI) bleeding.
12. Planned additional coronary or valvular percutaneous or surgical intervention scheduled within 30 days after index procedure.
13. Requires emergent or urgent PCI.
14. Positive pregnancy test result in women of child bearing potential or is breast-feeding.
15. Current participation in another investigational drug or device trial.
16. Other medical illnesses that may cause the subject to be non- compliant with the protocol or confound data interpretation.
17. Estimated Glomerular Filtration Rate (GFR) below 25 ml/min and not yet on dialysis.
18. Evidence of clinical instability (e.g., hemodynamic instability, sustained tachyarrhythmias, cardiogenic shock).
18 Years
ALL
No
Sponsors
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ethica Clinical Research Inc.
INDUSTRY
Cardiovascular Research Foundation, New York
OTHER
SoundBite Medical Solutions, Inc.
INDUSTRY
Responsible Party
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Locations
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Columbia University Medical Center/NYPH
New York, New York, United States
ICM - Institut de Cardiologie de Montreal
Montreal, Quebec, Canada
CHUM - Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
MUHC- McGill University Health Centre
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec - IUCPQ
Québec, Quebec, Canada
Countries
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Other Identifiers
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NAP-COR-2018-01
Identifier Type: -
Identifier Source: org_study_id