InSeal Vascular Closure Device Clinical Study Protocol

Percutaneous Closure of Artery Access Sites Clinical Trial

— VCD  

Official title:

InSeal Vascular Closure Device Clinical Study Protocol

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01896401
• Other study ID #: 13-14-003
• Status: Terminated
• Phase: N/A
• First received: July 6, 2013
• Last updated: February 22, 2016
• Start date: February 2012
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: InSeal Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Percutaneous Closure of Artery Access Sites

Intervention

Device:
• InSeal's Vascular Closure Device

Locations

Country	Name	City	State
Germany	Cardio Vascular Centrum Frankfurt	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
InSeal Medical Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Hemostasis within 15 minutes following vessel access site closure and after ACT falls below 200 second		15 minutes	No
Secondary	2. Combined rate of closure-device related major adverse events in first month		1 month	Yes