Safety and Efficacy Study of the SoundBiteâ„¢ Crossing System With ACTIVE Wire in Coronary CTOs. (NCT03521804) | Clinical Trial Compass
TerminatedNot Applicable
Safety and Efficacy Study of the SoundBiteâ„¢ Crossing System With ACTIVE Wire in Coronary CTOs.
Stopped: Business decision
United States, Canada35 participantsStarted 2018-06-21
Plain-language summary
The objective of this study is to evaluate the safety and efficacy of the SoundBiteâ„¢ Crossing System - Coronary (SCS-C) in a subject population with chronic coronary artery disease including Chronic Total Occlusion (CTO).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Device success
Timeframe: Day 1
2
Freedom from the composite SoundBiteâ„¢ Crossing System related MAEs