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

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: Completed
• Conditions: Vascular Closure
• Intervention / Treatment: Device: Cross-Seal System

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: Interventional
• Enrollment (Actual): 147
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Freedom From Major Complications	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)	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

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	Incidence of major and minor Adverse Events (AEs)	60 days post procedure
Incidence of Treatment Success	Incidence of Treatment Success: defined as technical success and freedom from major complications	30 days post procedure
Freedom From Minor Complications	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	Number of subjects with devices related complications as adjudicated by the Clinical Events Committee.	30 days post procedure
Incidence of Technical Success	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	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	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	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-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	Incidence of subjects experiencing Device Failure.	30 days post procedure
Incidence of Procedure Related Complications	Number of subjects with procedure related complications as adjudicated by the CEC.	30 days post procedure

Collaborators and Investigators

• Sponsor: Terumo Medical Corporation
• Investigators: 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

General Publications

• Krishnan P, Farhan S, Zidar F, Krajcer Z, Metzger C, Kapadia S, Moore E, Nazif T, Garland T, Zhang M, Khera S, Sharafuddin M, Patel VI, Bacharach JM, Coady P, Schermerhorn ML, Shames ML, Rahimi S, Panneton JM, Elkins C, Foteh M. Cross-Seal IDE Trial: Prospective, Multicenter, Single-Arm Study of the Cross-Seal Suture-Mediated Vascular Closure Device System. Circ Cardiovasc Interv. 2024 Jun;17(6):e013842. doi: 10.1161/CIRCINTERVENTIONS.123.013842. Epub 2024 May 6.

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2019
• Primary Completion (Actual): March 22, 2021
• Study Completion (Actual): March 22, 2021

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID 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