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

NCT03756558 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2025-09-15

Study results available
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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

Interventions

DEVICE

Cross-Seal System

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

Sponsors & Collaborators

  • Terumo Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Mazin Foteh, MD · Cardiothoracic and Vascular Surgeons - Austin

  • Prakash Krishnan · Icahan School of Medicine at Mt Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-09
Primary Completion
2021-03-22
Completion
2021-03-22
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03756558 on ClinicalTrials.gov