None listed
Conditions
Brief summary
This is a prospective, multi-center, first in human (FIH) study of the Shockwave Medical Fizz Fizz Peripheral System for the treatment of atherosclerotic, stenotic peripheral arteries. The objective of the study is to assess the safety and performance of the Shockwave Medical Fizz Fizz Peripheral System for the treatment of atherosclerotic, stenotic peripheral arteries.
Interventions
The Shockwave Fizz Fizz Peripheral System consists of the Fizz Fizz Peripheral Catheter, Fizz Fizz Peripheral Generator and Connector Cable, and the Fizz Fizz Peripheral Pump System and Accessories. The Fizz Fizz Peripheral System may be used by interventional radiologists, angiologists, or vascular surgeons. Activating the Fizz Fizz Peripheral Catheter
therapy delivers pulsatile mechanical energy to the lesion. After each 30-second cycle of therapy, the Fizz Fizz Peripheral Generator is progra
The Shockwave Fizz Fizz Peripheral System consists of the Fizz Fizz Peripheral Catheter, Fizz Fizz Peripheral Generator and Connector Cable, and the Fizz Fizz Peripheral Pump System and Accessories. The Fizz Fizz Peripheral System may be used by interventional radiologists, angiologists, or vascular surgeons. Activating the Fizz Fizz Peripheral Catheter therapy delivers pulsatile mechanical energy to the lesion. After each 30-second cycle of therapy, the Fizz Fizz Peripheral Generator is programmed to force a minimum pause time of 5 seconds in preparation for the next cycle. After this pause, additional cycles are delivered, as needed, to complete treatment. Each catheter is designed to deliver a maximum of 5 cycles and a maximum of 7500 pulses. Participants in this study will be adults between the ages of 18 and 80 years of age who are suffering from atherosclerotic, stenotic, peripheral artery disease in the superficial femoral (SFA) and popliteal arteries. This percutaneous peripheral interventional procedure consists of treatment of a target lesion within an SFA or popliteal artery with the Fizz Fizz Peripheral System, followed by destination therapy at the discretion of the Investigator. Destination therapy may include PTA, commercial IVL, bare-metal stent (BMS), drug-eluting stent (DES), or DCB. The procedure is a minimally invasive treatment that widens a blocked artery in the legs using a catheter. Interventions may be performed at a hospital by a licensed interventional radiologist, angiologist, or vascular surgeon. The average procedure time is around 30mins to 1 hour, but could take longer depending on the complexity of the disease. Integrity to the intervention will be monitored by peri-procedural imaging. Enrolled participants will be followed through discharge, 30 days, 6 months, and 12 months.
Sponsors
Shockwave Medical
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 80 Years
Healthy volunteers
No
Inclusion criteria
There is only one cohort in this study. Both, general and angiographic inclusion criteria apply to all participants in the study. General Inclusion Criteria 1. Subject is able and willing to comply with all assessments in the study. 2. Subject, or subject’s legal representative, has been informed of the nature of the study, agrees to participate and has signed the approved consent form. 3. Age of subject is greater than or equal to 18 years and less than or equal to 80 years. 4. Rutherford Clinical Category 3, 4 or 5 of the target limb. 5. Estimated life expectancy >1 year. Angiographic Inclusion Criteria 6. Single target lesion located in a native de novo superficial femoral, or popliteal (P1, P2) artery. 7. Target lesion stenosis greater than or equal to 70% by investigator visual estimate. 8. Target lesion reference vessel diameter (RVD) is between 4.0 mm and 7.0 mm by investigator visual estimate. 9. Target lesion length is less than or equal to 150 mm by investigator visual estimate. 10. At least one patent tibial vessel on the target limb with runoff to the foot (<50% stenosis). 11. Successful guidewire placement through the distal end of the target lesion. Successful crossing is defined as advancing the tip of the guidewire distal to the target lesion without the use of a re-entry device and with no serious angiographic complications (e.g., dissection, embolism). 12. Successful embolic protection placement in a suitable location distal to the target lesion. Successful placement includes delivery and placement with no serious angiographic complications (e.g., dissection, embolism).
Exclusion criteria
There is only one cohort in this study. Both, general and angiographic exclusion criteria apply to all participants in the study. General Exclusion Criteria: 1. Rutherford Clinical Category 0, 1, 2, and 6 (target limb). 2. Subject has an active infection requiring antibiotic therapy. 3. History of endovascular or surgical procedure on the target limb within the last 30 days, or planned within 30 days of the index procedure, with the exception of toe amputation(s). 4. Planned use of cutting/scoring balloons, re-entry or atherectomy devices to treat the target lesion during the index procedure. 5. Subject in whom antiplatelet or anticoagulant therapy is contraindicated. 6. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated. 7. Subject has known allergy to any of the catheter component materials. 8. Myocardial infarction within 60 days prior to enrollment. 9. History of stroke within 60 days prior to enrollment. 10. Subject has acute or chronic renal disease with Estimated Glomerular Filtration Rate (eGFR) <30ml/min/1.73 m2, unless on renal replacement therapy. 11. Subject is pregnant or nursing. 12. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint. 13. Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment, or impact the scientific soundness of the clinical investigation result. 14. Active COVID-19 or previously diagnosed COVID-19 with sequelae that could confound endpoint assessments. 15. Planned major amputation of target limb. 16. Acute limb ischemia Angiographic Exclusion Criteria: 17. Failure to successfully treat clinically significant non-target lesion(s) prior to treatment of the target lesion. Successful treatment is defined as achieving less than or equal to 30% residual stenosis without the use of cutting/scoring balloons, re-entry or atherectomy devices, without flow-limiting dissection (greater than or equal to Grade D), and without serious angiographic complications (e.g. perforation, distal embolization, acute vessel closure) of the non-target lesion(s). Note: Non-target lesion(s) distal to the target lesion, or found after the target lesion is treated, may be treated after the target lesion. 18. Target lesion includes in-stent restenosis. 19. Evidence of aneurysm or appearance of acute thrombus in target vessel. 20. Target lesion within native or synthetic vessel grafts. 21. Subject has a target lesion that, in the opinion of the investigator, should not be treated, i.e. the risks associated with treating a particular target lesion outweigh the potential benefits for the patient. Considering factors include but are not limited to, the overall health of the subject, comorbidities, and the expected efficacy of the investigational treatment.
Outcome results
None listed