Pivotal Trial to Evaluate the Safety and Efficacy of the Diamondback 360°® Orbital Atherectomy System in Treating De Novo, Severely Calcified Coronary Lesions (ORBIT II)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Abbott Medical Devices
- Enrollment
- 443
- Locations
- 51
- Primary Endpoint
- Primary Safety Endpoint: 30-Day Freedom From Major Adverse Cardiac Events (MACE)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a prospective, single-arm, multi-center study to evaluate the safety and performance of the OAS in treating de novo, severely calcified coronary lesions in adult subjects. Study is going to enroll up to 429 subjects in up to 50 U.S. study sites. The primary safety endpoint is 30-day MACE and primary efficacy endpoint is procedural success. All subjects will be treated with the orbital atherectomy system and adjunctive stent. All subjects will be followed in clinic at 30 days. Additionally, all subjects will have an annual phone call or clinical follow up at each anniversary until study is closed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must be 18 or older.
- •Subjects must have a clinical indication for coronary intervention.
- •CK and CK-MB must be less than or equal to the upper limit of lab normal value within 8 hours prior to the procedure.
- •The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure.
- •The target vessel must be a native coronary artery with a stenosis of \>= 70% and \< 100%.
- •The target vessel reference diameter must be \>= 2.5mm and \<= 4.0 mm.
- •The lesion length must not exceed 40 mm.
- •The target vessel must have a TIMI flow 3 at baseline.
- •The target lesion must have evidence of severe calcium deposit at the lesion site based on the protocol criterion.
- •The lesion must be crossable with the study guide wire.
Exclusion Criteria
- •Inability to understand the study or a history of non-compliance with medical advice.
- •Unwilling or unable to sign the ORBIT II Informed Consent Form (ICF).
- •History of any cognitive or mental health status that would interfere with study participation.
- •Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.).
- •Female subjects who are pregnant or planning to become pregnant within the study period.
- •Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel without adequate alternative medications.
- •Known sensitivity to contrast media, which cannot be adequately pre-medicated.
- •Diagnosed with chronic renal failure or has a serum creatinine level \>2.5 mg/dl.
- •Experienced acute MI (STEMI or non-STEMI: CK and CK-MB greater than 1 times the upper limit of lab normal) within 30 days prior to index procedure.
- •History of major cardiovascular intervention within 30 days.
Outcomes
Primary Outcomes
Primary Safety Endpoint: 30-Day Freedom From Major Adverse Cardiac Events (MACE)
Time Frame: 30 days
OAS safety was measured by a composite of MACE at 30-days post procedure. MACE is composed of: * Cardiac death. * MI - defined as a CK-MB level \> 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave. * TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure.
Primary Efficacy Endpoint: Procedural Success
Time Frame: Participants were followed from baseline procedure through the duration of hospital stay, an average of 33.6 hours.
Procedural success was defined as success in facilitating stent delivery with a residual stenosis of \<50% and without the occurrence of an in-hospital MACE in de novo, severely calcified coronary lesions.
Secondary Outcomes
- Severe Angiographic Complications(Baseline procedure, with a mean total procedure time of 52.5 minutes.)
- 12-Month Freedom From Major Adverse Cardiac Events (MACE)(12 months)
- Angiographic Success(Baseline procedure, with a mean total procedure time of 52.5 minutes.)