InSeal Vascular Closure Device Clinical Study Protocol

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01896401

Acronym

VCD

Enrollment

Registered

2013-07-11

Start date

2012-02-29

Completion date

2015-08-31

Last updated

2016-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Percutaneous Closure of Artery Access Sites

Keywords

large bore endovascular catheterization procedures, Vascular Closure Device

Brief summary

The InSeal vascular closure device (VCD)is assessed as percutaneous closure of artery access sites for quick hemostasis and ambulation in patients who have undergone large bore endovascular catheterization procedures. The study hypothesis is that the VCD is safe and efficaient in achieving hemostasis in the study population.

Interventions

DEVICEInSeal's Vascular Closure Device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Candidate for large bore catheterization procedure (such as TAVI, aortic endograft repair) using a CE approved 18Fr access sheath. * Subject age is at least 18 years * Patient has signed most recent approved version of the Informed Consent * Existence of an additional arterial access port is required in instances where an occluding balloon is planned to be used as a safety precaution.

Exclusion criteria

* Women Of Child Bearing Potential (WOCBP) * Legally non-competent patients * Patient participating in another clinical study at the time of the InSeal VCD study * Prior target artery closure with a vascular closure device having intravascular component (such as Angio-Seal) 30 days prior to catheterization * Subjects with known coagulopathy, preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the vessel access site prior to artery closure * Patients that do not tolerate aspirin and clopidogrel anticoagulation treatment * Prior vascular surgery or vascular graft in region of access site * Significant calcification, atherosclerotic disease, or stent within 1.5 cm of the puncture site that may interfere with the operation of the experimental device

Design outcomes

Primary

Measure	Time frame
1. Hemostasis within 15 minutes following vessel access site closure and after ACT falls below 200 second	15 minutes

Secondary

Measure	Time frame
2. Combined rate of closure-device related major adverse events in first month	1 month

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026