Safety and Efficacy Study of the SoundBite™ Crossing System With ACTIVE Wire in Coronary CTOs.

NCT03521804 | Terminated DMC FDA Device

• 1 other identifier: NAP-COR-2018-01
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 5

Brief Summary

The objective of this study is to evaluate the safety and efficacy of the SoundBite™ Crossing System - Coronary (SCS-C) in a subject population with chronic coronary artery disease including Chronic Total Occlusion (CTO).

Conditions

Chronic Total Occlusion of Coronary Artery

Keywords

Chronic Total Occlusion; coronary; SoundBite™ Crossing System; CTO; distal cap; true lumen; Active wire; Device; Procedure; Stenosis; CAD; Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• Device success

  Device Success defined as: Successful antegrade crossing of the CTO into the true arterial lumen distal to the occlusion following advancement of at least 3 mm of the Soundbite(TM) Crossing System into any segment as assessed by the core angiographic laboratory. An antegrade only approach may involve Antegrade Dissection Re-Entry (ADR) with or without the use of specialized devices (e.g. Stingray); absence of successful retrograde crossing of a collateral will still be considered an antegrade only approach.

  Day 1

• Freedom from the composite SoundBite™ Crossing System related MAEs

  Freedom from the composite SoundBite™ Crossing System related major adverse events (MAEs) at 48 hours or hospital discharge (whichever occurs first) post procedure, as per Clinical Events Committee (CEC) adjudication, defined as: * Cardiovascular related deaths * Myocardial Infarction (Primary definition of clinically relevant post procedure MI from SCAI (1). * Coronary Artery Perforation requiring treatment * Unscheduled cardiac surgery anytime between enrollment to completion of the study. * Intra-procedure stroke * Radiation exposure ≥ 8 Gy

  48 hours or until discharge

Secondary Outcomes (5)

• Overall Device Success

  Day 1

• Technical Success

  Day 1

• Procedural Success

  Day 1

• Clinical Success:

  30 days post-procedure

• Freedom from SoundBite™ Crossing System related MAE

  30 days post-procedure

Study Arms (1)

SoundBite™ Crossing System-Coronary

OTHER

Crossing of coronary chronic total occlusions.

Device: SoundBite™ Crossing System Active Wire 14

Interventions

SoundBite™ Crossing System Active Wire 14 DEVICE

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.

SoundBite™ Crossing System-Coronary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject planned to undergo clinically driven percutaneous coronary intervention (PCI) targeting a single CTO. Clinical justification of a CTO PCI includes anginal symptoms, dyspnea or left ventricular dysfunction presumed or documented to be the result of ischemia in the CTO territory.
• PCI procedure is planned to be performed with a wire based antegrade primary strategy.
• Subject is ≥ 18 years old.
• Subject is able and willing to provide written informed consent prior to study procedure.
• Target CTO is in a native coronary artery and demonstrates TIMI flow grade 0.
• Target CTO is presumed documented angiographically to be greater than 3 months old.
• Target CTO length is visually estimated to be ≥ 5mm.
• Target reference vessel diameter ≥ 2.5mm.
• Target CTO shows calcification.
• 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.

You may not qualify if:

• Life expectancy \< 1 year.
• 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.
• Target occlusion has an iatrogenic dissection that occurred within the past 3 months.
• Subject has received ≥5 Gy exposure to the chest within 3 months.
• Subject has known elevated cardiac biomarkers (CK-MB or cTn) within 30 days prior to index procedure.
• Left ventricular ejection fraction less than 20%.
• Severe aortic or mitral valve disease.
• Planned left ventricular (LV) support device during CTO PCI.
• History of bleeding diatheses, coagulopathy.
• Recent (within 6 months prior to index procedure) stroke or transient ischemic attack (TIA).
• Recent (within 6 months prior to index procedure) significant gastrointestinal (GI) bleeding.
• Planned additional coronary or valvular percutaneous or surgical intervention scheduled within 30 days after index procedure.
• Requires emergent or urgent PCI.
• Positive pregnancy test result in women of child bearing potential or is breast-feeding.
• Current participation in another investigational drug or device trial.

Sponsors & Collaborators

• SoundBite Medical Solutions, Inc.: lead
• ethica Clinical Research Inc.: collaborator
• Cardiovascular Research Foundation, New York: collaborator

Study Sites (5)

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

Location

ICM - Institut de Cardiologie de Montreal

Montreal, Quebec, H1T 1C8, Canada

Location

CHUM - Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0C1, Canada

Location

MUHC- McGill University Health Centre

Montreal, Quebec, H3A 3J1, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec - IUCPQ

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Constriction, Pathologic; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 11, 2018
• Study Start: June 21, 2018
• Primary Completion: October 21, 2020
• Study Completion: November 20, 2020
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (4)