Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT03756558
Eligibility Criteria:
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 femoral artery using 8-18 French introducer sheaths
3. Subject is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery
4. Subject is willing and able to complete follow-up requirements
5. Subject, or authorized representative signs a written Informed Consent form prior participating in the study
Exclusion Criteria:
General Exclusion Criteria
1. Prior intra-aortic balloon pump at access site
2. Subjects with severe inflow disease (iliac artery diameter stenosis \> 50%) and/or severe peripheral arterial disease (Rutherford Classification 5 or 6), as confirmed with prior standard of care Computed Tomography Imaging, duplex ultrasound, and/or intra-procedural fluoroscopy
3. Common femoral artery lumen diameter is \< 5 mm
4. In opinion of the investigator, significant scarring of the target access site which would preclude use of the device in accordance with the IFU
5. Prior target artery closure with any closure device \< 90 days, or closure with manual compression ≤ 30 days prior to index procedure
6. Prior vascular surgery, vascular graft, or stent in region of access site
7. Subjects receiving glycoprotein IIb/IIIa inhibitors before, during, or after the catheterization procedure
8. Subjects with significant anemia
9. Subject with known bleeding disorder including thrombocytopenia (platelet count \< 100,000), thrombasthenia, hemophilia or Von Willebrand's disease
10. Subject with renal insufficiency, on dialysis therapy, or with renal transplant
11. Known severe allergy to contrast reagent that cannot be managed with premedication
12. Inability to tolerate aspirin and/or other anticoagulation/antiplatelet treatment
13. Planned anticoagulation therapy post-procedure such that the Activated Clotting Time (ACT) is expected to be elevated above 350 seconds for more than 24 hours after the procedure
14. Connective tissue disease (e.g., Marfan's Syndrome)
15. Thrombolytics (e.g., streptokinase, urokinase), Angiomax (bivalirudin) or other thrombin-specific anticoagulants ≤ 24 hours prior to the procedure
16. Recent (within 8 weeks) cerebrovascular accident or Q-wave myocardial infarction
17. Subjects who are morbidly obese
18. Planned major intervention or surgery, including planned endovascular procedure in the target leg, within 30 days following the interventional procedure
19. Subject unable to ambulate at baseline (i.e., confined to wheelchair or bed)
20. Currently participating in a clinical study of an investigational device or drug that has not completed its primary study endpoint
21. Known allergy to any device component
22. Subject is known or suspected to be pregnant or lactating
23. Evidence of active systemic or local groin infection
24. Subject has other medical, social or psychological problem that in the opinion of the investigator precludes them from participating
25. Subject is mentally incompetent or a prisoner
26. New York Heart Association (NYHA) Class IV heart failure that is uncontrolled and requires treatment in the Intensive Care Unit within 24 hours prior to the index procedure
27. Left Ventricular Ejection Fraction (LVEF) \< 20%
28. Unilateral or bilateral lower extremity amputation
29. Known existing nerve damage in the target leg
30. Subjects who have already participated in this study
Intra-Procedure Exclusion Criteria
31. Access site above the most inferior border of the inferior epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks
32. Access site in the profunda femoris or superficial femoral arteries, or the bifurcation of these vessels
33. Ipsilateral femoral venous sheath during the catheterization procedure
34. Common femoral artery calcium, which is visible with prior Computed Tomography Imaging and/or duplex ultrasound
35. Subject in which there is difficulty inserting the introducer sheath or need for greater than 2 ipsilateral arterial punctures at the start of the catheterization procedure
36. Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture
37. Evidence of a pre-existing hematoma (\> 1.5 cm in diameter), arteriovenous fistula, pseudoaneurysm, or intraluminal thrombosis at the access site
38. Marked tortuosity (at the investigator's discretion) of the femoral or external iliac artery in the target leg based on prior Computed Tomography imaging, fluoroscopy, and/or duplex ultrasound
39. Angiographic evidence of arterial laceration, dissection, or stenosis in the femoral artery that would preclude use of the investigational device
40. Target arteriotomy \>18 French sheath
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03756558
Study Brief:
Protocol Section:
NCT03756558