Shockwave Medical Mini C Flex Feasibility Study
- Conditions
- Coronary Artery DiseaseCardiovascular - Coronary heart disease
- Registration Number
- ACTRN12623000436673
- Lead Sponsor
- Shockwave Medical Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
General Inclusion Criteria
1. Subject is greater than or equal to 18 years of age
2. Subject is able and willing to comply with all assessments in the study.
3. Subjects with native coronary artery disease including stable or unstable angina or silent ischemia associated with the target coronary artery that are suitable for non-emergent PCI
4. Biomarkers (troponin) must be less than or equal to the upper limit of lab normal within 12 hours prior to the procedure.
5. Left ventricular ejection fraction greater than 25%
6. Subject signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures
7. Estimated life expectancy greater than 1 year.
Angiographic Inclusion Criteria
8. The target lesion must be a de novo coronary lesion that has not been previously treated successfully with any interventional procedure
9. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with stenosis greater than or equal to 70%
10. The target vessel reference diameter must be greater than or equal to 2.5 mm and less than or equal to 4.0 mm
11. The lesion length must not exceed 40 mm
12. The target lesion must meet one of the following criteria:
a) Evidence of moderate or severe calcification at the lesion site and with TIMI flow 0 or 1 at baseline. Moderate calcification defined as angiography with densities noted only during the cardiac cycle prior to contrast injection; severe calcification defined as: angiography with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall), OR
b) Documented evidence of a prior device un-crossable lesion (>3 days prior to the index procedure)
13. Guidewire must be in true lumen, distal to the lesion, and not subintimal, prior to insertion of Mini C catheter (antegrade wire technique only)
General Exclusion Criteria
1. Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
2. Subject is participating in another research study involving an investigational agent including pharmaceutical, biologic, or medical device that has not reached the primary endpoint
3. Subject is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment)
4. Unable to tolerate antiplatelet/anticoagulation therapy per society guidelines
5. Subject has an allergy to imaging contrast media which cannot be adequately pre-medicated
6. Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure, defined as clinical symptoms consistent with an acute coronary syndrome with troponin greater than 1 times the local laboratory’s upper limit of normal
7. Subject has acute or chronic renal disease with eGFR less than 30 ml/min/1.73m2 (using CKD-EPI formula)
8. History of a stroke or transient ischemic attack (TIA) within 60 days, or any prior intracranial hemorrhage or permanent neurologic deficit
9. Active peptic ulcer or upper gastrointestinal (GI) bleeding within 3 months
10. Untreated pre-procedural hemoglobin <10 g/dL or intention to refuse blood transfusions if one should become necessary
11. Coagulopathy, including but not limited to platelet count <100,000 or International Normalized ratio (INR) greater than 1.7 (INR is only required in subjects who have taken warfarin within 2 weeks of enrollment)
12. Subject has a hypercoagulable disorder such as polycythemia vera, platelet count greater than 750,000 or other disorders
13. Uncontrolled diabetes defined as a HbA1c ?greater than or equal to 10%
14. Subject has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics
15. Subjects with clinical evidence of cardiogenic shock
16. Uncontrolled severe hypertension (systolic BP greater than 180 mm Hg or diastolic BP greater than 110 mm Hg)
17. Subjects with a life expectancy of less than 1 year
18. Non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days prior to the index procedure
19. Planned non-coronary interventional or surgical structural heart procedures (e.g., TAVR, MitraClip, LAA or PFO occlusion, etc.) within 30 days after the index procedure
20. Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery
21. Planned use of atherectomy, scoring or cutting balloon, sub-intimal reentry device, or any investigational device other than coronary IVL
Angiographic Exclusion Criteria
22. Evidence of moderate or severe calcification at the lesion site and with TIMI flow 2 to3 at baseline
23. Target vessel is excessively tortuous defined as the presence of two or more bends greater than 90º or three or more bends greater than 75º
24. Evidence of a serious angiographic complication in the target vessel prior to treatment with coronary IVL (severe dissection (Type D to F), perforation, abrupt closure, persistent slow-flow or persistent no reflow)
25. Definite or possible thrombus by angiography in the target vessel
26. Evidence of aneurysm in target vessel within 10 mm of the target lesion
27. Second lesion with greater than 50% stenosis in the same target vessel as the target lesion including its s
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method