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

Terumo

Status

Completed

Conditions

Vascular Closure

Treatments

Device: Cross-Seal System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03756558

TIS2018-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment

147 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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