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

Completed · Not applicable

Conditions studied: Vascular Closure

In brief

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.

Key facts

Study ID

NCT03756558

Run by

Terumo Medical Corporation

People needed

147

Starts

2019-08-09

Expected to finish

2021-03-22

Last updated by the study team

2025-09-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Vascular Institute of the Rockies — Denver, Colorado, United States
• River City Clinical Research — Jacksonville, Florida, United States
• University of South Florida — Tampa, Florida, United States
• University of Iowa Hospital — Iowa City, Iowa, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Rutgers, The State University of New Jersey — Piscataway, New Jersey, United States
• Mt Sinai Medical Center — New York, New York, United States
• The Trustees of Columbia University in the City of New York — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• Good Samaritan Hospital — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• INTEGRIS Cardiovascular Physicians — Oklahoma City, Oklahoma, United States
• Lankenau Institute for Medical Research — Wynnewood, Pennsylvania, United States
• North Central Heart — Sioux Falls, South Dakota, United States
• Holston Valley Medical Center — Kingsport, Tennessee, United States
• Cardiothoracic and Vascular Surgeons — Austin, Texas, United States
• St. David's Heart and Vascular dba Austin heart — Austin, Texas, United States
• Texas Heart Institute and Baylor St. Luke's Medical Center — Houston, Texas, United States
• Sentara Medical Group — Norfolk, Virginia, United States
• Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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