Safety and Effectiveness Clinical Study of Novelrad Vascular Closure System (NVCS)

This study evaluates the safety and effectiveness of the Novelrad Vascular Closure System (NVCS), a suture-mediated vascular closure system, in achieving post-procedure hemostasis in subjects undergoing interventional catheterization procedures through the common femoral artery using large-bore procedural sheaths.

Inclusion Criteria: 1. Subject is ≥18 years old. 2. Subject is scheduled for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedures involving access through the common femoral artery using 8-22 French introducer sheaths such as TAVI/TAVR/EVAR/TEVAR etc. 3. Subject has common femoral artery diameter ≥ 6 mm and accepted calcification status as evaluated on pre-procedural CT angiography by the investigator and by the Sponsor, if requested. 4. Subject is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery. 5. Understand and sign the study specific written informed consent form. 6. Able and willing to fulfill the follow-up requirements. Exclusion Criteria: Baseline Exclusions: 1. Known to be pregnant or lactating. 2. Immunocompromised or with pre-existing autoimmune disease. 3. Systemic infection or a local infection at or near the access site. 4. Significant anemia (Hgb \< 9 g/dL hematocrit \40 kg/m2 or \50% stenosis is not considered preventing the use of NVCD, it must be recorded as such). Intra-Procedural Exclusions: 1. On baseline Duplex US the Common femoral artery \50% stenosis of the femoral artery. 2. Stenosis \>50% diameter of access site's ipsilateral iliac artery that the investigator determines may interfere with the NVCD (if the \>50% stenosis is not considered preventing the use of NVCD, it must be recorded as such). 3. Puncture site took place in the profunda femoris artery, superficial femoral artery, or at the bifurcation of these arteries or if less than one third of the access needle is above the skin line indicating the subject is morbidly obese. 4. Common femoral artery suspected to have experienced a back wall puncture or underwent \> 2 arterial punctures, during the catheterization procedure. 5. Difficult dilation from initial femoral artery access (e.g., damaging or kinking dilators). 6. Actual puncture site located above the most inferior border of the epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks. 7. Marked tortuosity of femoral or iliac artery that to the opinion of the user prohibiting the use of the device. 8. Systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mm Hg, unless systolic or diastolic pressure can be lowered by pharmacological agents prior to closure. 9. Planned antegrade puncture during the index procedure. 10. Presence of ipsilateral femoral venous sheath during the interventional procedure. 11. Systolic blood pressure \22 Fr. 14. Evidence of a pre-existing hematoma (\> 2 cm in diameter), arteriovenous fistula, pseudoaneurysm, or intraluminal thrombosis at the access site before insertion of the NVCD. 15. Imaging (Duplex Ultrasound / Angiography) evidence of arterial laceration, dissection, or stenosis in the femoral artery that would preclude use of the device.