Vascular ClosureNCT03756558

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

A study testing Cross-Seal System in people with Vascular Closure, run by Terumo Medical Corporation at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Vascular Closure
What is being tested?: Cross-Seal System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 147 participants
Where: 20 sitesUnited States
Study dates: 9 Aug 2019to 22 Mar 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

General Exclusion Criteria
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

Show all 42Show fewer

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
Recent (within 8 weeks) cerebrovascular accident or Q-wave myocardial infarction
Subjects who are morbidly obese
Planned major intervention or surgery, including planned endovascular procedure in the target leg, within 30 days following the interventional procedure
Subject unable to ambulate at baseline (i.e., confined to wheelchair or bed)
Currently participating in a clinical study of an investigational device or drug that has not completed its primary study endpoint
Known allergy to any device component
Subject is known or suspected to be pregnant or lactating
Evidence of active systemic or local groin infection
Subject has other medical, social or psychological problem that in the opinion of the investigator precludes them from participating
Subject is mentally incompetent or a prisoner
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
Left Ventricular Ejection Fraction (LVEF) < 20%
Unilateral or bilateral lower extremity amputation
Known existing nerve damage in the target leg
Subjects who have already participated in this study
Intra-Procedure Exclusion Criteria
Access site above the most inferior border of the inferior epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks
Access site in the profunda femoris or superficial femoral arteries, or the bifurcation of these vessels
Ipsilateral femoral venous sheath during the catheterization procedure
Common femoral artery calcium, which is visible with prior Computed Tomography Imaging and/or duplex ultrasound
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
Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture
Evidence of a pre-existing hematoma (> 1.5 cm in diameter), arteriovenous fistula, pseudoaneurysm, or intraluminal thrombosis at the access site
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
Angiographic evidence of arterial laceration, dissection, or stenosis in the femoral artery that would preclude use of the investigational device
Target arteriotomy >18 French sheath

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

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

Other trials in United States

About this study

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

Read the 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.

Conditions: Vascular Closure
Being tested: Cross-Seal System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03756558
Study group	Role	What they receive
Cross-Seal System	Experimental	The Cross-Seal System will be used in all subjects enrolled in the study Receives: Device: Cross-Seal System

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: Index Procedure

Secondary outcomes (11)

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
Measured: 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.
Measured: 30 days post procedure
Incidence of Adverse Events
Incidence of major and minor Adverse Events (AEs)
Measured: 60 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).
Measured: 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
Measured: Within 48 hours of the index procedure or hospital discharge, whichever occurs first
Incidence of Treatment Success
Incidence of Treatment Success: defined as technical success and freedom from major complications
Measured: 30 days post procedure
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 30 days post procedure
Incidence of Procedure Related Complications
Number of subjects with procedure related complications as adjudicated by the CEC.
Measured: 30 days post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Aug 201922 Mar 2021

First posted28 Nov 2018
Study start9 Aug 2019
Primary completion22 Mar 2021
Study completion22 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Vascular ClosureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Performance goal
Masking: None (open label)
Enrolment: 147 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03756558
Sponsor's protocol ID: TIS2018-01
Status last verified: Jun 2024
First submitted: 30 Oct 2018
Last updated: 15 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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.
PubMed 38708595

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Vascular Closure trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cross-SealTM IDE Trial: Prospective, Multi-Center, Single Arm Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System
ClinicalTrials.gov ID: NCT03756558
Acronym / sponsor ID: TIS2018-01
Conditions: Vascular Closure
Study type: Interventional
Recruitment status: Completed
Enrolment: 147 participants (actual)
Lead sponsor: Terumo Medical CorporationIndustry (pharma, biotech, devices)
Study start: 9 Aug 2019 (actual)
Primary completion: 22 Mar 2021 (actual)
Study completion: 22 Mar 2021 (actual)
First posted: 28 Nov 2018 (actual)
Results: Posted 15 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Performance goal

Arm	Type	Receives
Cross-Seal System	Experimental	Device: Cross-Seal SystemThe Cross-Seal System will be used in all subjects enrolled in the study

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (42 listed)

General Exclusion Criteria
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cross-Seal SystemUse of the Cross-Seal system to close the femoral arteriotomy	Device	Cross-Seal System

Primary outcome

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
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.

11 secondary outcomes

Freedom From Minor Complications
Time frame: 30 days post procedure
Number of Participants With Device Related Complications Within 30 Days Post-procedure
Time frame: 30 days post procedure
Incidence of Adverse Events
Time frame: 60 days post procedure
Incidence of Technical Success
Time frame: 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 Treatment Success
Time frame: 30 days post procedure
Incidence of Surgical or Endovascular Intervention Post Closure
Time frame: 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
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
Incidence of Device Failure
Time frame: 30 days post procedure
Incidence of Procedure Related Complications
Time frame: 30 days post procedure

Results and safety

Results posted to the registry on 15 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Transfemoral Approach	147	142

Primary outcome: Freedom From Major Complications

Time frame: 30 days post procedure. Count of participants. Unit: Participants

Measure	Transfemoral Approach n = 88
Value	83

Population analysed: Pivotal safety cohort included 96 subjects from the full analysis set, comprising all enrolled and treated subjects who experienced at least one component for the safety endpoint or were follow-up to the lower limit of the follow-up window for each time point. Due to missing data from 8 subjects, the analysis was conducted with 88 subjects.

Primary outcome: Mean Time To Hemostasis (TTH)

Time frame: Index Procedure. Mean (Standard Deviation). Unit: Minutes

Measure	Transfemoral Approach n = 101
Value	0.4 (1.4)

Population analysed: Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). Number of participants analyzed is 101 as 9 subjects who had an adjunctive intervention and 4 subjects who did not receive the investigational device.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: From time of enrollment through study completion (up to 60 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cross-Seal System	42 of 147 (28.6%)	63 of 147 (42.9%)	1 of 147

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38708595Krishnan 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.
Individual participant dataSharing planned: No

Related trials for Vascular Closure

Recruiting
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Ischemic Stroke, Atrial Fibrillation
Recruiting
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Patent Foramen Ovale, Ischemic Stroke
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mazin Foteh, MD principal investigator

Cardiothoracic and Vascular Surgeons - Austin

Prakash Krishnan principal investigator

Icahan School of Medicine at Mt Sinai

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cross-Seal System in people with Vascular Closure, run by Terumo Medical Corporation at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom From Major Complications (time frame: 30 days post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03756558, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.