Status:
COMPLETED
Cross-Seal Closure Device IDE Trial - Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System
Lead Sponsor:
Terumo Medical Corporation
Conditions:
Vascular Closure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 f...
Detailed 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 l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2021
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT03756558
Start Date
August 9 2019
End Date
March 22 2021
Last Update
September 15 2025
Active Locations (20)
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1
Vascular Institute of the Rockies
Denver, Colorado, United States, 80218
2
River City Clinical Research
Jacksonville, Florida, United States, 32207
3
University of South Florida
Tampa, Florida, United States, 33620
4
University of Iowa Hospital
Iowa City, Iowa, United States, 52242