CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 61 enrolled
Drug / intervention
Sapphire II PROdevice
Likely dose
Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters for pre-dilation of coronary arteries or bypass graftsAI-extracted
Key inclusion· 5
  • ✓Age ≥18 years
  • ✓Single or double vessel coronary artery disease with clinical evidence of ischemic heart disease (stable/unstable angina or silent ischemia)
  • ✓De novo or restenotic lesion(s) in native coronary arteries or bypass grafts suitable for PCI; embolic protection device required for all saphenous venous graft interventions
  • ✓Maximum of two lesions (including at least one target lesion) in up to two different coronary arteries or bypass grafts
Key exclusion· 11
  • ✕Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, anti-platelet medications, or contrast media that cannot be adequately pre-medicated
  • ✕Acute myocardial infarction within 72 hours prior to index procedure
  • ✕Pregnancy or nursing status
  • ✕Target lesion treatment planned with unapproved device, atherectomy, laser, cutting balloon, or thrombectomy during index procedure

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03052530
NCT03052530N/ACompleted
CompareCT.gov

Sapphire II PRO - A Prospective, Open Label, Multi-center, Single Arm, Observational Study Designed to Evaluate the Acute Safety and Device Procedural Success of the Sapphire II PRO 1.0 and 1.25 mm PTCA Dilatation Catheters.

OrbusNeich·interventional·Posted Feb 14, 2017·Updated May 11, 2018

In Brief

A clinical study evaluating Sapphire II PRO for Coronary Artery Disease and 5 related conditions. Completed, enrolled 61 participants across 4 sites.

Detailed Summary

A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device procedural success of the Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters in subjects with stenotic coronary arteries or bypass grafts during percutaneous coronary intervention. Sixty (60) subjects will be treated at up to 5 U.S. sites with the Sapphire II PRO diameters 1.0 and 1.25 mm PTCA dilatation catheters to pre-dilate coronary arteries or bypass grafts during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through hospital discharge.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases
CountriesUnited States
CollaboratorsIcahn School of Medicine at Mount Sinai

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 14, 2017
Enrollment StartMay 5, 2017
Primary CompletionJul 24, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 9.4 years ago

Interventions

Sapphire II PROdevice

To pre-dilate coronary arteries or bypass grafts during the subject's index procedure with Sapphire II PRO 1.0 and 1.25 PTCA dilatation catheters.