X-Seal EU Post-Market Clinical Follow-Up Protocol

Inclusion criteria

• Candidate for non-emergent diagnostic or interventional cardiac catheterization via a femoral sheath ≤6F.
• Age ≥18 years.
• Understand and sign the study specific written informed consent form.
• In the investigator's opinion, the patient is suitable for the X-Seal vascular closure device, conventional hemostasis techniques and participation in an investigational trial.
• Eligible for sheath removal in the catheterization lab.

Exclusion criteria

• Patients who are known to be pregnant or lactating.
• Patients who are immunocompromised.
• Prior target artery closure with any vascular closure device or closure with manual compression win 30 days prior to this procedure.
• Patients with significant anemia (hemoglobin <10 g/DL, Hct<30).
• Patients who are morbidly obese or cachectic (BMI >40 or <20 kg/m2).
• Patients with Systolic Blood Pressure >180 mmHg, unless Systolic Pressure can be lowered by pharmacological agents prior to closure
• Patients who are currently participating in another clinical trial of an investigational drug or device that has not concluded the follow-up period.
• Patients with a baseline INR > 1.5 (e.g. coumadin therapy).
• Patients with a known bleeding disorder including thrombocytopenia (platelet count <100,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand's disease.
• Patients with small femoral arteries (<4 mm), femoral artery stenosis resulting in a vessel diameter <4 mm, or patients with severe peripheral vascular disease.
• Patients with puncture site believed to be in the profunda femoris, superficial femoral artery, or at the bifurcation of the arteries.
• Common femoral artery with fluoroscopically visible calcium.
• Femoral arteries that are suspected to have experienced a back wall puncture or that underwent >one (1) arterial puncture during the catheterization procedure.
• Patients having a complication(s) at the femoral artery access site pre-sheath removal including hematoma, pseudoaneurysm, or arterio-venous fistula.
• Patients in whom continued heparin or other anticoagulant/antiplatelet therapy is planned (with the exception of Glycoprotein IIb/IIIa receptor blockers) following completion of the catheterization procedure.
• Patients whose ACT is >300 seconds prior to removal of the guiding catheter.
• Patients who cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence or life threatening disease.
• Prior femoral vascular surgery or vascular graft in region of access site.
• Patient is unable to ambulate at baseline.
• Acute ST-elevation MI within 48 hours prior to procedure.
• Active systemic or cutaneous infection or inflammation
• Patients with unilateral or bilateral lower extremity amputation
• Patients with renal insufficiency (serum creatinine >2.5 mg/dl)
• Patients with marked tortuosity of the femoral or iliac artery
• Patients in whom bacterial contamination of the procedure sheath or surrounding tissues may have occurred as this may result in infection
• Patients in whom the puncture site is located above the most inferior border of the epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks, since such a puncture site may result in a retroperitoneal hematoma/bleed. Perform a femoral angiogram to verify the location of the puncture site
• Patients with known allergies to beef products, collagen and/or collagen products, or polyglycolic or polylactic acid polymers
• Patients with known allergy to stainless steel or nickel. See MRI information in the IFU.
• Patients undergoing therapeutic thrombolysis
• Patients punctured through a vascular graft