NL-OMON43455
Completed
Not Applicable
Prospective Multi-Center, Single Arm Study of the Shockwave Coronary Rx Lithoplasty® System in Coronary Arteries - Shockwave heart study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- arterial stenosis
- Sponsor
- Shockwave Medical Inc.
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patient is \> 18 years of age
- •2\. Troponin must be less than or equal to the upper limit of lab normal value within 12 hours prior to the procedure
- •3\. The target vessel must have a TIMI flow 3 at baseline
- •4\. Patients with significant (\> 50% diameter stenosis) native coronary artery disease including stable or unstable angina and silent ischemia, suitable for PCI
- •5\. Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel, prasugrel, or ticagrelor for 1 year and single antiplatelet therapy for life
- •6\. Single lesion stenosis of protected LMCA, LAD, RCA or LCX artery \*50% in a reference vessel of 2\.5 mm \- 4\.0 mm diameter and \* 32 mm length
- •7\. Presence of calcification within the lesion on both sides of the vessel as assessed by angiography
- •8\. Planned treatment of single lesions per vessel
- •9\. Ability to pass a 0\.014\* guide wire across the lesion
- •10\. Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study\-mandated procedures
Exclusion Criteria
- •1\. Concomitant use of Atherectomy, Specialty balloon, or investigational coronary devices
- •2\. Prior PCI procedure within the last 30 days of the index procedure
- •3\. Patient has planned cardiovascular interventions within 30 days post index procedure
- •4\. Second lesion with \>50% stenosis in the same target vessel
- •5\. Left ventricular ejection fraction \< 40%
- •6\. Patient refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
- •7\. Uncontrolled severe hypertension (systolic BP \>180 mm Hg or diastolic BP \>110 mm Hg)
- •8\. Severe renal failure with serum creatinine \>2\.5 mg/dL
- •9\. Untreated pre\-procedural hemoglobin \<10 g/dL
- •10\. Coagulopathy manifested by platelet count \<100,000 or International Normalized ratio (INR) \>1\.7 (INR is only required in patients who have taken warfarin within 2 weeks of enrollment)
Outcomes
Primary Outcomes
Not specified
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