Cross-Seal Closure Device IDE Trial - Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System

Study Overview
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Brief Summary
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This study evaluates the safety and effectiveness of the Cross-Seal vascular closure device in gaining post procedure hemostasis in subjects undergoing interventional procedures requiring an 8 to 18 french size introducer sheath.

Detailed Description
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The Cross-Seal device is a VCD intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (8-18F ID) interventional devices. The function of Cross-Seal is to percutaneously close the puncture in the artery wall (arteriotomy) through which the catheters were inserted for the procedure. The study is being conducted to demonstrate the safety and effectiveness of Cross-Seal in achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous transcatheter interventional procedures using a large-bore procedure sheath.

Official Title
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Cross-SealTM IDE Trial: Prospective, Multi-Center, Single Arm Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System

Conditions
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Vascular Closure

Intervention / Treatment
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* Device: Cross-Seal System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is ≥ 18 years old 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 Subject is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery Subject is willing and able to complete follow-up requirements Subject, or authorized representative signs a written Informed Consent form prior participating in the study Exclusion Criteria: General Exclusion Criteria Prior intra-aortic balloon pump at access site 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 Common femoral artery lumen diameter is < 5 mm In opinion of the investigator, significant scarring of the target access site which would preclude use of the device in accordance with the IFU 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 Subjects receiving glycoprotein IIb/IIIa inhibitors before, during, or after the catheterization procedure Subjects with significant anemia Subject with known bleeding disorder including thrombocytopenia (platelet count < 100,000), thrombasthenia, hemophilia or Von Willebrand's disease Subject with renal insufficiency, on dialysis therapy, or with renal transplant Known severe allergy to contrast reagent that cannot be managed with premedication Inability to tolerate aspirin and/or other anticoagulation/antiplatelet treatment 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 Connective tissue disease (e.g., Marfan's Syndrome) Thrombolytics (e.g., 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 Subjects who are morbidly obese Planned major intervention or surgery, including planned endovascular procedure in the target leg, within 30 days following the interventional procedure Subject unable to ambulate at baseline (i.e., confined to wheelchair or bed) Currently participating in a clinical study of an investigational device or drug that has not completed its primary study endpoint Known allergy to any device component Subject is known or suspected to be pregnant or lactating Evidence of active systemic or local groin infection Subject has other medical, social or psychological problem that in the opinion of the investigator precludes them from participating Subject is mentally incompetent or a prisoner 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 Left Ventricular Ejection Fraction (LVEF) < 20% Unilateral or bilateral lower extremity amputation Known existing nerve damage in the target leg Subjects who have already participated in this study Intra-Procedure Exclusion Criteria 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 visible with prior Computed Tomography Imaging and/or duplex ultrasound 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 Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture Evidence of a pre-existing hematoma (> 1.5 cm in diameter), arteriovenous fistula, pseudoaneurysm, or intraluminal thrombosis at the access site 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 Angiographic evidence of arterial laceration, dissection, or stenosis in the femoral artery that would preclude use of the investigational device Target arteriotomy >18 French sheath

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Performance goal
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cross-Seal System<br>The Cross-Seal System will be used in all subjects enrolled in the study | Device: Cross-Seal System<br>* Use of the Cross-Seal system to close the femoral arteriotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from Major Complications | Freedom from major complications of the target limb. Major Complications include: access site vascular injury that requires surgical intervention, access related lower extremity ischemia, access site infection | 30 days post procedure | 
| Mean Time To Hemostasis (TTH) | The mean Time To Hemostasis in the Common Femoral Artery (CFA) of the target limb access site with use of the investigational device. | 30 days post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from minor complications | The freedom from minor complications at the target limb access site. Minor Complications include: pseudoaneurysm at the access site, access site hematoma over 10cm, access site wound dehiscence | 30 days post procedure | 
| Incidence of Device and procedural complications | Adverse Events occurring in the study will be evaluated for device and/or procedural relationships to the device by the study investigator and/or Clinical Events Committee. The incidence reported will not include units, but rather be presented for each event as the occurrence rate by percentage (n/N, proportion) as applicable. | 30 days post procedure | 
| Incidence of Adverse Events | Incidence of major and minor Adverse Events (AEs) | 60 days post procedure | 
| Incidence of Technical Success | Incidence of hemostasis with the investigational device without the need for any access-site-related adjunctive surgical or endovascular intervention (target limb only). | 30 days post procedure | 
| Incidence of Closure Success | Incidence of access site closure success: defined as technical success and freedom from major complications | up to 30 days | 
| Incidence of Treatment Success | Incidence of Treatment Success: defined as technical success and freedom from major complications | 30 days post procedure | 
| Incidence of surgical or endovascular intervention post closure | Subjects requiring adjunctive surgical or endovascular intervention to achieve hemostasis of the access site (target limb only) including type of adjunctive intervention. | 30 days post procedure | 
| Incidence of Manual Compression | Incidence of subjects requiring adjunctive manual compression following use of the investigational device to achieve hemostasis of the access site (target limb only). | 30 days post procedure | 
| Time-to-Ambulation: | Time-to-Ambulation: defined as elapsed time from final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding. | up to 30 days | 
| Incidence of Device Failure | Incidence of device failure | 30 days post procedure |