Business decision

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).

The study is intended to demonstrate that the SoundBite™ Crossing System - Coronary can facilitate the passage of either 1) devices intended to treat a CTO or 2) guidewires or additional crossing devices into the true lumen distal to the CTO.

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.

General inclusion Criteria

1. 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.
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.

Angiographic Inclusion Criteria All angiographic inclusion criteria shall be documented at time of index procedure. Angiographic inclusion criteria are assessed at the site and determined by the site investigator.

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.

General Exclusion Criteria

1. Life expectancy < 1 year.
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).

Angiographic Exclusion Criteria All angiographic inclusion criteria shall be documented at time of index procedure. Angiographic exclusion criteria are assessed at the site and determined by the site investigator.

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