Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation

Launched by UNIVERSITY HOSPITAL, ESSEN · Jul 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how effective a new treatment called the SELUTION SLR is for patients with peripheral artery disease (PAD), which causes poor blood flow in the legs. The trial aims to see if this new treatment can improve blood vessel function and help manage symptoms better than traditional methods. Participants will undergo a procedure that involves using a special balloon to open up blocked arteries in the thigh area and will be monitored over time to see how well the treatment works.

To be eligible for this study, participants need to be between 18 and 85 years old and have diagnosed PAD with specific types of leg blockages. They should also be willing to attend follow-up appointments and sign consent forms. This trial is currently recruiting, and participants can expect to have their health closely monitored for 12 months after the treatment to track the effects on their blood vessels. If someone has certain health conditions or recent medical issues, they may not be eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Peripheral artery disease
• • Target lesions 3 cm distal to the CFA-bifurcation including SFA and PA lesions
• • Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, 4 and 5
• • Planed peripheral intervention TASC A-D
• • Subject must be between 18 and 85 years old
• • Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation
• • Vessel diameter ≥4.0 mm and ≤7.0 mm
• • Willing to comply with the specified follow-up evaluation
• • Written informed consent prior to any study procedures
• • Pretreatment with an adequately sized balloon
• Exclusion Criteria:
• • Bifurcational lesions of the CFA and lesions including the first 3 cm of the SFA, due to technical aspects of FMD measurement
• • Instent-Restenosis
• • Thrombolysis within 72 hours prior to the index procedure
• • Aneurysm formations in the femoral artery or popliteal artery
• • Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy
• • Unstable angina pectoris at the time of the enrollment
• • Recent myocardial infarction or stroke \< 30 days prior to the index procedure
• • Life expectancy less than 12 months