Clinical Study of the Medeon Biodesign XProâ„¢ (NCT03171155) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study of the Medeon Biodesign XProâ„¢
Australia, New Zealand28 participantsStarted 2017-05-25
Plain-language summary
To access the safety and performance of the XPro System to facilitate hemostasis in patients undergoing percutaneous endovascular procedures utilizing 8-18 Fr introducer sheath via the common femoral.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient is \> 18 years old
* Patient is scheduled for percutaneous BAV, TAVR/TAVI, EVAR, or TEVAR involving access through the femoral artery using an 8-18 Fr introducer sheath
* Patient is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery
* Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated procedures
* Patient is willing and able to complete follow-up
Exclusion Criteria:
* Prior intra-aortic balloon pump at access site
* Patients with severe claudication, iliac or femoral artery diameter stenosis greater than 50%
* Common femoral artery lumen diameter is \< 6 mm
* Prior target artery closure with any closure device \< 90 days, or closure with manual compression ≤ 30 days prior to index procedure
* Prior vascular surgery, vascular graft, or stent in region of access site
* Patients receiving glycoprotein IIb/IIIa inhibitors before, during, or after the catheterization procedure
* Patients with significant anemia ((Hgb \< 10 g/dL, Hct \< 30%)
* Patient with known bleeding disorder including thrombocytopenia (platelet count \< 100,000), thrombasthenia, hemophilia or Von Willebrand's disease
* Patients with renal insufficiency (serum creatinine level \> 221µmol/L) or renal transplant
* Known allergy to contrast reagent
* Inability to tolerate aspirin and/or other anticoagulation treatment
* Planned antico…