None listed
Conditions
Brief summary
The Shockwave Medical Mini C Flex Feasibility Study is to assess the safety and performance of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Mini C Flex and Javelin Coronary IVL Catheters for the treatment of calcified, stenotic de novo coronary arteries prior to stenting. Participants in this study will have a pre and post procedure pathway that is similar to the conventional method of managing / treating these coronary artery blockages. The difference of participation in the study will be the use of the Shockwave Medical Mini C Flex and Javelin Coronary IVL catheters to treat the calcified plaque within the coronary artery. The subject will then progress to normal destination therapy. Subjects who chose to participate will be followed at discharge, 30 days, 6 months and 12 months following their procedure.
Interventions
The Mini C Flex Feasibility Study is being conducted to assess the safety and performance of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Mini C Flex and Javelin Coronary IVL Catheters for the treatment of heavily calcified, stenotic de novo coronary arteries prior to stenting.
The Shockwave Mini C Flex and Javelin Coronary IVL Catheters will be used in a cardiac angiography laboratory and delivered by an interventional cardiologist with specific skills in managing su
The Mini C Flex Feasibility Study is being conducted to assess the safety and performance of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Mini C Flex and Javelin Coronary IVL Catheters for the treatment of heavily calcified, stenotic de novo coronary arteries prior to stenting. The Shockwave Mini C Flex and Javelin Coronary IVL Catheters will be used in a cardiac angiography laboratory and delivered by an interventional cardiologist with specific skills in managing subjects with severely calcified and heavily stenosed coronary arteries. Subjects may have one coronary artery treated with the Shockwave Medical Mini C or Javelin Coronary IVL Catheter. The Mini C Flex IVL Catheter was used for initial subjects and was then modified to the Javelin Coronary IVL Catheter, which was used for the remaining subjects. The catheter will be inserted into a peripheral artery over a guidewire. The catheter will then be delivered to the affected coronary artery and pressurised before pulses are delivered. The procedure will take approximately one hour. Post operative care is in alignment with what is considered to be standard of care for subjects undergoing such a procedure. The study follow up is also in alignment with standard of care practices for subjects with this degree of coronary artery disease. This post procedure and follow up care involves monitoring for cardiac complications and the administration of medications. Such information would be gained from the subject's medical history and any resulting diagnostic tests.
Sponsors
Shockwave Medical Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 angina or following stabilization after acute coronary syndrome (ACS) that are suitable for non-emergent PCI 4. Biomarkers (troponin) must be: a) less than or equal to the upper limit of lab normal within 12 hours prior to the procedure; OR b) if above the upper limit of lab normal, biomarker result must be less than 5 times the upper limit of lab normal within 12 hours prior to the procedure and the following criterion must be met: • The procedure must be elective (not emergent) and the subject cannot have angina at rest. 5. Subject signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures 6. Estimated life expectancy >1 year. 7. Lesions in non-target vessels requiring PCI may be treated either: a) >30 days prior to the study procedure if the procedure was unsuccessful or complicated; OR b) >24 hours prior to the study procedure if the procedure was successful and uncomplicated, defined as a final lesion angiographic diameter stenosis normal; OR c) >30 days after the study procedure Angiographic Inclusion Criteria 8. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure 9. Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) 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 target lesion must meet one of the following criteria: a) Target lesion stenosis >90% up to 40 mm in length and evidence of moderate or severe calcification at the lesion site. 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) Chronic total occlusion presenting with J-CTO score of 1 with evidence of calcification and occlusion length up to 20 mm 12. Guidewire must be in true lumen, distal to the lesion, and not subintimal, prior to insertion of Javelin Coronary catheter (antegrade wire technique only)
Exclusion criteria
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 STEMI within 30 days prior to index procedure 7. Subject has acute or chronic renal failure with eGFR 180 mm Hg or diastolic BP >110 mm Hg) 16. Subjects with a life expectancy of less than 1 year 17. Non-coronary interventional or surgical structural heart procedures (e.g., TAVR, TEER, LAA or PFO occlusion, etc.) within 30 days prior to the index procedure 18. Planned non-coronary interventional or surgical structural heart procedures (e.g., TAVR, TEER, LAA or PFO occlusion, etc.) within 30 days after the index procedure 19. Subject refusing or not a candidate for emergency coronary artery bypass grafting (CABG) surgery 20. Planned use of atherectomy, scoring or cutting balloon, sub-intimal reentry device, or any investigational device other than coronary IVL Angiographic Exclusion Criteria 21. Evidence of a serious angiographic complication in the target vessel prior to treatment with coronary IVL (dissection, perforation, abrupt closure, persistent slow-flow or persistent no reflow) 22. Definite or possible thrombus by angiography in the target vessel 23. Evidence of aneurysm in target vessel within 10 mm of the target lesion 24. Second lesion with >50% stenosis in the same target vessel as the target lesion including its side branches 25. Chronic total occlusion, J-CTO greater than or equal to 2 26. Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft 27. Previous stent within 5 mm of the target lesion 28. Failure to successfully cross the guidewire across the target lesion 29. Use of antegrade dissection and reentry (ADR), retrograde guidewire (RW), or retrograde dissection and reentry (RDR) crossing technique at any time during the procedure.
Outcome results
None listed