Percutaneous Closure of Arteriotomy in Common Femoral Artery
Conditions
Brief 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.
Detailed description
This is a prospective multi-center, single arm study to assess the safety and performance of the XPro System compared to a historical control developed from published studies of two marketed competitive devices, Perclose ProGlide® and Prostar® XL (both from Abbott Vascular, Inc., Redwood City, CA, USA). The goal of the study is to show that XPro System is non-inferior to the competitors in efficacy and safety. Patients scheduled for percutaneous BAV, TAVR/TAVI, EVAR, or TEVAR procedures using an 8-18 Fr introducer sheath will be screened for study eligibility. Patients will be followed for 30 days post procedure.
Interventions
DEVICEXPro System
Implantation of the XPro System
Sponsors
Medeon Biodesign, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Implantation of the XPro System
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 anticoagulation therapy post-procedure such that ACT is expected to be elevated above 350 seconds for more than 24 hours after the procedure * Connective tissue disease (e.g., Marfan's Syndrome) * Thrombolytics (e.g. t-PA, streptokinase, urokinase), Angiomax (bivalirudin) or other thrombin-specific anticoagulants ≤ 24 hours prior to the procedure * Recent (within 8 weeks) cerebrovascular accident or Q-wave myocardial infarction * Patients who are morbidly obese BMI \> 40 kg/m2 * Planned major intervention or surgery within 30 days following the interventional procedure * Patients who are unable to ambulate at baseline * Currently participating in a clinical study of an investigational device or drug that has not completed study endpoint * Known allergy to any device component * Patient is known or suspected to be pregnant or lactating * Life expectancy \< 1 year as judged by the investigator * Patient has other medical, social or psychological problem that in the opinion of the investigator precludes them from participating Intra-Procedure * Access site above the most inferior border of the inferior epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks * Access site in the profunda femoris or superficial femoral arteries, or the bifurcation of these vessels * Ipsilateral femoral venous sheath during the catheterization procedure * Common femoral artery calcium, which is fluoroscopically visible * Patients where there is difficulty inserting the introducer sheath or greater than 2 ipsilateral arterial punctures at the start of the catheterization procedure * Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture * Evidence of a pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site * Patients with intra-procedural bleeding around access site * Evidence of active systemic or local groin infection * Patients receiving glycoprotein IIb/IIIa inhibitors during, or after the catheterization procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Hemostasis | 15 minutes | Time to hemostasis absent of any access-site-related adjunctive surgical or endovascular procedures. |
| Freedom from major VARC-2 events | Up to 30 days of procedure | Freedom from major VARC-2 events within 30 days of the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from access-site infection | Up to 30 days of procedure | Freedom from access-site infection requiring IV or IM antibiotics, or extended hospitalization or re-hospitalization. |
| Successful hemostasis with the XPro System | at 48 hours or at discharge from hospital, whichever comes first; and up to 30 days post-procedure | Without the need for any access-site-related adjunctive surgical or endovascular procedures and freedom from major VARC-2 events. |
| Freedom from minor VARC-2 events | Up to 30 days of procedure | Freedom from minor VARC-2 events up to 30 days of the procedure. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to ambulation | Up to 48 hours | Defined as elapsed time from sheath removal and time when the patient stands and walks at least 20 feet without re-bleeding. |
| Time to hospital discharge | Up to 2 weeks | Time to actual hospital discharge defined as elapsed time from sheath removal to actual physical discharge from the hospital. |
Countries
Australia, New Zealand, Taiwan
Outcome results
None listed