Percutaneous Closure of Arteriotomy in Common Femoral Artery Clinical Trial
Official title:
Prospective, Multi-Center, Single Arm Study of the Medeon Biodesign XPro™ Suture-Mediated Vascular Closure Device System
Verified date | September 2019 |
Source | Medeon Biodesign, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | September 12, 2019 |
Est. primary completion date | July 25, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Australia | St. Vincent's Hospital Melbourne | Fitzroy | Victoria |
Australia | Royal North Shore Hospital | St Leonards | New South Wales |
New Zealand | Auckland City Hospital | Auckland | |
New Zealand | Christchurch Hosptial | Christchurch | |
New Zealand | Waikato Hospital | Hamilton | |
Taiwan | China Medical University Hospital | Taichung |
Lead Sponsor | Collaborator |
---|---|
Medeon Biodesign, Inc. |
Australia, New Zealand, Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Time to ambulation | Defined as elapsed time from sheath removal and time when the patient stands and walks at least 20 feet without re-bleeding. | Up to 48 hours | |
Other | Time to hospital discharge | Time to actual hospital discharge defined as elapsed time from sheath removal to actual physical discharge from the hospital. | Up to 2 weeks | |
Primary | Time to Hemostasis | Time to hemostasis absent of any access-site-related adjunctive surgical or endovascular procedures. | 15 minutes | |
Primary | Freedom from major VARC-2 events | Freedom from major VARC-2 events within 30 days of the procedure. | Up to 30 days of procedure | |
Secondary | Freedom from minor VARC-2 events | Freedom from minor VARC-2 events up to 30 days of the procedure. | Up to 30 days of procedure | |
Secondary | Successful hemostasis with the XPro System | Without the need for any access-site-related adjunctive surgical or endovascular procedures and freedom from major VARC-2 events. | at 48 hours or at discharge from hospital, whichever comes first; and up to 30 days post-procedure | |
Secondary | Freedom from access-site infection | Freedom from access-site infection requiring IV or IM antibiotics, or extended hospitalization or re-hospitalization. | Up to 30 days of procedure |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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Safety and Performance Study of Large Hole Vascular Closure Device
|
N/A |