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

September 11, 2025 updated by: Terumo Medical Corporation

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
147

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
        • Vascular Institute of the Rockies
    • Florida
      • Jacksonville, Florida, United States, 32207
        • River City Clinical Research
      • Tampa, Florida, United States, 33620
        • University of South Florida
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • New Jersey
      • Piscataway, New Jersey, United States, 08854
        • Rutgers, The State University of New Jersey
    • New York
      • New York, New York, United States, 10029
        • Mt Sinai Medical Center
      • New York, New York, United States, 10032
        • The Trustees of Columbia University in the City of New York
      • Rochester, New York, United States, 14642
        • University of Rochester
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • INTEGRIS Cardiovascular Physicians
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Institute for Medical Research
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • North Central Heart
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Holston Valley Medical Center
    • Texas
      • Austin, Texas, United States, 78756
        • Cardiothoracic and Vascular Surgeons
      • Austin, Texas, United States, 78756
        • St. David's Heart and Vascular dba Austin heart
      • Houston, Texas, United States, 77030
        • Texas Heart Institute and Baylor St. Luke's Medical Center
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Sentara Medical Group
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

General 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
  11. Known severe allergy to contrast reagent that cannot be managed with premedication
  12. Inability to tolerate aspirin and/or other anticoagulation/antiplatelet treatment
  13. 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
  14. Connective tissue disease (e.g., Marfan's Syndrome)
  15. Thrombolytics (e.g., streptokinase, urokinase), Angiomax (bivalirudin) or other thrombin-specific anticoagulants ≤ 24 hours prior to the procedure
  16. Recent (within 8 weeks) cerebrovascular accident or Q-wave myocardial infarction
  17. Subjects who are morbidly obese
  18. Planned major intervention or surgery, including planned endovascular procedure in the target leg, within 30 days following the interventional procedure
  19. Subject unable to ambulate at baseline (i.e., confined to wheelchair or bed)
  20. Currently participating in a clinical study of an investigational device or drug that has not completed its primary study endpoint
  21. Known allergy to any device component
  22. Subject is known or suspected to be pregnant or lactating
  23. Evidence of active systemic or local groin infection
  24. Subject has other medical, social or psychological problem that in the opinion of the investigator precludes them from participating
  25. Subject is mentally incompetent or a prisoner
  26. 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
  27. Left Ventricular Ejection Fraction (LVEF) < 20%
  28. Unilateral or bilateral lower extremity amputation
  29. Known existing nerve damage in the target leg

  30. Subjects who have already participated in this study

    Intra-Procedure Exclusion Criteria

  31. Access site above the most inferior border of the inferior epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks
  32. Access site in the profunda femoris or superficial femoral arteries, or the bifurcation of these vessels
  33. Ipsilateral femoral venous sheath during the catheterization procedure
  34. Common femoral artery calcium, which is visible with prior Computed Tomography Imaging and/or duplex ultrasound
  35. 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
  36. Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture
  37. Evidence of a pre-existing hematoma (> 1.5 cm in diameter), arteriovenous fistula, pseudoaneurysm, or intraluminal thrombosis at the access site
  38. 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
  39. Angiographic evidence of arterial laceration, dissection, or stenosis in the femoral artery that would preclude use of the investigational device
  40. Target arteriotomy >18 French sheath

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cross-Seal System
The Cross-Seal System will be used in all subjects enrolled in the study
Device: Cross-Seal System
Use of the Cross-Seal system to close the femoral arteriotomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Freedom From Major Complications
Time Frame: 30 days post procedure
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)
Time Frame: Index Procedure
The mean Time To Hemostasis in the Common Femoral Artery (CFA) of the target limb access site with use of the investigational device.
Index Procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events
Time Frame: 60 days post procedure
Incidence of major and minor Adverse Events (AEs)
60 days post procedure
Incidence of Treatment Success
Time Frame: 30 days post procedure
Incidence of Treatment Success: defined as technical success and freedom from major complications
30 days post procedure
Freedom From Minor Complications
Time Frame: 30 days post procedure
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
Number of Participants With Device Related Complications Within 30 Days Post-procedure
Time Frame: 30 days post procedure
Number of subjects with devices related complications as adjudicated by the Clinical Events Committee.
30 days post procedure
Incidence of Technical Success
Time Frame: Immediately Post-procedure (procedure approximately 8 hours)
Incidence of hemostasis with the investigational device without the need for any access-site-related adjunctive surgical or endovascular intervention (target limb only).
Immediately Post-procedure (procedure approximately 8 hours)
Incidence of Closure Success
Time Frame: Within 48 hours of the index procedure or hospital discharge, whichever occurs first
Incidence of access site closure success: defined as technical success and freedom from major complications
Within 48 hours of the index procedure or hospital discharge, whichever occurs first
Incidence of Surgical or Endovascular Intervention Post Closure
Time Frame: 30 days post procedure
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
Time Frame: Post-procedure, following use of the investigational device until achieve hemostasis, assessed approximately up to 48 hours
Incidence of subjects requiring adjunctive manual compression following use of the investigational device to achieve hemostasis of the access site (target limb only).
Post-procedure, following use of the investigational device until achieve hemostasis, assessed approximately up to 48 hours
Time-to-Ambulation:
Time Frame: From the final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding, assessed up to approximately 48 hours
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.
From the final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding, assessed up to approximately 48 hours
Incidence of Device Failure
Time Frame: 30 days post procedure
Incidence of subjects experiencing Device Failure.
30 days post procedure
Incidence of Procedure Related Complications
Time Frame: 30 days post procedure
Number of subjects with procedure related complications as adjudicated by the CEC.
30 days post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Terumo Medical Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mazin Foteh, MD, Cardiothoracic and Vascular Surgeons - Austin
  • Principal Investigator: Prakash Krishnan, Icahan School of Medicine at Mt Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 9, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 22, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 22, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TIS2018-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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