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Cross-Seal Closure Device IDE Trial - Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System | Clinical Trials | Clareo Health

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

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

NCT03756558•Terumo Medical Corporation

View on ClinicalTrials.gov

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 french size introducer sheath.

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 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject is ≥ 18 years old
•2. 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
•3. Subject is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery
•4. Subject is willing and able to complete follow-up requirements
•5. Subject, or authorized representative signs a written Informed Consent form prior participating in the study

Exclusion Criteria

•1. Prior intra-aortic balloon pump at access site
•2. 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
•3. Common femoral artery lumen diameter is \< 5 mm
•4. In opinion of the investigator, significant scarring of the target access site which would preclude use of the device in accordance with the IFU
•5. Prior target artery closure with any closure device \< 90 days, or closure with manual compression ≤ 30 days prior to index procedure
•6. Prior vascular surgery, vascular graft, or stent in region of access site
•7. Subjects receiving glycoprotein IIb/IIIa inhibitors before, during, or after the catheterization procedure
•8. Subjects with significant anemia
•9. Subject with known bleeding disorder including thrombocytopenia (platelet count \< 100,000), thrombasthenia, hemophilia or Von Willebrand's disease
•10. Subject with renal insufficiency, on dialysis therapy, or with renal transplant
+30 more criteria

Locations (20)

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

Key Dates

Start Date

August 9, 2019

Primary Completion Date

March 22, 2021

Completion Date

March 22, 2021

Last Updated

September 15, 2025

Enrollment

147

ACTUAL participants

Conditions

Vascular Closure

Interventions

Cross-Seal System

DEVICE

The Ladera Suture-Mediated Large Bore Closure Study

NCT06851481

Vascular ClosureFemoral Arteriotomy Closure

View study

ACTIVE_NOT_RECRUITINGNA

The Ladera Large Bore Closure Feasibility Study

NCT06358157

Vascular ClosureFemoral Arteriotomy Closure

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

The Ladera Suture-Mediated Large Bore Closure Study

The Ladera Large Bore Closure Feasibility Study

Safety and Efficacy of the Vascular Closure Device (Tonbridge) in Hemostasis Treatment of Femoral Artery Puncture

PerQseal® Impella Early Feasibility Study

Patient Comfort With Vascular Closure