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

NCT03756558 | Completed Results DMC FDA Device

• 1 other identifier: TIS2018-01
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 20

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 french size introducer sheath.

Conditions

Vascular Closure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Freedom From Minor Complications

  30 days post procedure

• Number of Participants With Device Related Complications Within 30 Days Post-procedure

  30 days post procedure

• Incidence of Adverse Events

  60 days post procedure

• Incidence of Technical Success

  Immediately Post-procedure (procedure approximately 8 hours)

• Incidence of Closure Success

  Within 48 hours of the index procedure or hospital discharge, whichever occurs first

Study Arms (1)

Cross-Seal System

EXPERIMENTAL

The Cross-Seal System will be used in all subjects enrolled in the study

Device: Cross-Seal System

Interventions

Cross-Seal System DEVICE

Use of the Cross-Seal system to close the femoral arteriotomy

Cross-Seal System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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

Sponsors & Collaborators

• Terumo Medical Corporation: lead

Study Sites (20)

Vascular Institute of the Rockies

Denver, Colorado, 80218, United States

Location

River City Clinical Research

Jacksonville, Florida, 32207, United States

Location

University of South Florida

Tampa, Florida, 33620, United States

Location

University of Iowa Hospital

Iowa City, Iowa, 52242, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Rutgers, The State University of New Jersey

Piscataway, New Jersey, 08854, United States

Location

Mt Sinai Medical Center

New York, New York, 10029, United States

Location

The Trustees of Columbia University in the City of New York

New York, New York, 10032, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

INTEGRIS Cardiovascular Physicians

Oklahoma City, Oklahoma, 73112, United States

Location

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096, United States

Location

North Central Heart

Sioux Falls, South Dakota, 57108, United States

Location

Holston Valley Medical Center

Kingsport, Tennessee, 37660, United States

Location

Cardiothoracic and Vascular Surgeons

Austin, Texas, 78756, United States

Location

St. David's Heart and Vascular dba Austin heart

Austin, Texas, 78756, United States

Location

Texas Heart Institute and Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

Sentara Medical Group

Norfolk, Virginia, 23502, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Related Publications (1)

• 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.

  PMID: 38708595 DERIVED

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Terumo Medical Corporation

charis.sugden@terumomedical.com

9085146154

Study Officials

• Mazin Foteh, MD

  Cardiothoracic and Vascular Surgeons - Austin

  PRINCIPAL INVESTIGATOR

• Prakash Krishnan

  Icahan School of Medicine at Mt Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Performance goal

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 28, 2018
• Study Start: August 9, 2019
• Primary Completion: March 22, 2021
• Study Completion: March 22, 2021
• Last Updated: September 15, 2025
• Results First Posted: September 15, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)