Evaluation of the Sapphire 3 catheter for treating blocked coronary arteries
Sapphire 3 - A Prospective, Open Label, Multi-center, Single Arm, Observational Study Designed to Evaluate the Acute Safety and Device Performance of the Sapphire 3 0.85-1.25 mm Coronary Dilatation Catheter in Predilatation of Chronic Total Occlusion (CTO) Lesions During Percutaneous Coronary Intervention.
NA · OrbusNeich · NCT06358508
This study is testing a new catheter to see if it can safely help people with completely blocked coronary arteries during a heart procedure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | OrbusNeich (industry) |
| Locations | 10 sites (Miami, Florida and 9 other locations) |
| Trial ID | NCT06358508 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and performance of the Sapphire 3 coronary dilatation catheter in patients with chronic total occlusion (CTO) lesions during percutaneous coronary intervention. It is a prospective, open-label, multi-center, single-arm observational study involving 170 subjects across up to 15 clinical sites. Participants will undergo a procedure where the catheter is used to pre-dilate CTO lesions, and their outcomes will be monitored for 24 hours post-procedure or until hospital discharge.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with single or double vessel coronary artery disease and clinical evidence of ischemic heart disease scheduled for percutaneous revascularization.
Not a fit: Patients with non-CTO lesions or those not scheduled for percutaneous coronary intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety and effectiveness of treating coronary artery disease in patients with chronic total occlusions.
How similar studies have performed: Other studies have shown success with similar catheter-based approaches in treating coronary artery disease, indicating a promising avenue for this intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Clinical Inclusion Criteria:
1. Subject is ≥ 18 years of age.
2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedures.
3. Subject must agree not to participate in any other clinical study during hospitalization for the index procedure that would interfere with the endpoints of this study.
4. Subjects must have a single or double vessel coronary artery disease and clinical evidence of ischemic heart disease, such as stable / unstable angina or silent ischemia attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization with planned stent placement during this index procedure.
Angiographic Inclusion Criteria
5. Subject must have at least one de novo or restenotic lesion in native coronary arteries with Thrombolysis In Myocardial Infarction (TIMI) flow grade of 0 or 1 and is estimated to be at least 3 months in duration by clinical, angiographic, or electrocardiographic criteria.
6. A maximum of two lesions, including at least one target lesion, in up to two coronary arteries.
7. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success by visual assessment.
8. The Target lesion is intended for stent placement during this index procedure.
Clinical Exclusion Criteria:
1. Subject with a known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, anti-platelet medications, or sensitivity to contrast media which cannot be adequately pre-medicated.
2. Evidence of acute myocardial infarction (MI) within 72 hours prior to the intended treatment defined as CK-MB or troponin greater than 1X the upper limit of normal (ULN).
3. Subject with known pregnancy or is nursing. Women of child- bearing potential should have a documented negative pregnancy test within 7 days before index procedure.
4. Planned or actual target lesion treatment prior to the use of the Study Device with an unapproved device, atherectomy, laser, cutting balloon or thrombectomy during the index procedure.
5. A serum creatinine level \> 2.0 mg/dl within seven days prior to index procedure.
6. Cerebrovascular accident (CVA) within the past 6 months.
7. Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 months.
8. Subject has a known left ventricular ejection fraction (LVEF) \<30% (LVEF may be obtained at the time of the index procedure if the value is unknown, if necessary).
Angiographic Exclusion Criteria
9. More than two lesions requiring treatment.
10. Unprotected left main coronary artery disease. (Greater than 50% diameter stenosis).
11. Coronary artery spasm of the target vessel in the absence of a significant stenosis.
12. Target lesion with angiographic presence of probable or definite thrombus of TIMI thrombus grade 3 or 4.
13. By visual estimation, target lesion involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch \>2.25 mm in diameter.
14. Previous coronary interventional procedure of any kind within the 30 days prior to the procedure in the target vessel.
15. Target vessel with a patent bypass graft from prior coronary bypass surgery.
16. Previous stenting (drug-eluting or bare metal) in the target vessel unless all the following conditions are met:
* It has been at least 9 months since the previous stenting.
* That target lesion is at least 15 mm away from the previously placed stent. Total occlusions involving an in-stent segment are excluded.
* The previously stented segment (stent plus 5 mm on either side) has no more than 40% diameter stenosis.
17. Non-target lesion to be treated during the index procedure meets any of the following criteria:
* Located within a bypass graft (venous or arterial)
* Left main location
* Chronic total occlusion (CTO)
* Is moderately to severely calcified.
* Involves a bifurcation (e.g., bifurcations requiring treatment with more than 1 stent)
* Treatment not deemed a clinical angiographic success
Where this trial is running
Miami, Florida and 9 other locations
- University of Miami — Miami, Florida, United States (RECRUITING)
- Emory University Hospital Midtown — Atlanta, Georgia, United States (RECRUITING)
- Piedmont Heart Institute — Atlanta, Georgia, United States (RECRUITING)
- Emory University Hospital — Atlanta, Georgia, United States (RECRUITING)
- Emory St. Joseph's Hospital — Atlanta, Georgia, United States (RECRUITING)
- Atlanta VA Health Care System — Decatur, Georgia, United States (RECRUITING)
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
- Brigham and Women's Hospital Heart and Vascular Center — Boston, Massachusetts, United States (RECRUITING)
- Henry Ford Health System — Detroit, Michigan, United States (RECRUITING)
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: David Kandzari, MD — Piedmont Heart Institute
- Study coordinator: Debbie Morrell, MSME
- Email: dmorrell@orbusneich.com
- Phone: 954-343-6467
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Cardiovascular Diseases, Chronic Total Occlusion, Chronic Total Occlusion of Coronary Artery