Clinical Investigation Plan (CIP) for Safety and Efficacy Study of Arterial Closure Device (CELT ACD). Clinical Investigation Plan No.: CIP-TS-003

Vasorum Ltd5 sites in 3 countries241 target enrollmentMay 2012

ConditionsCardiac Disease Coronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiac Disease
Sponsor: Vasorum Ltd
Enrollment: 241
Locations: 5
Primary Endpoint: The Primary Safety Endpoint Will be the Combined Rate of Major Complications With in 30 +/- 7 Days Following the Percutaneous Coronary Intervention (PCI) Procedure.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of the CELT ACD® Vascular Closure Device study is to evaluate the safety and effectiveness of the CELT ACD® device to achieve hemostasis of the common femoral artery access site in patients on anticoagulation who are undergoing a percutaneous intervention (PCI) procedure using a 6F sheath.

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

February 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vasorum Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Over 18 years of age.
•Each patient, or his or her guardian or legal representative, is willing to give informed consent.
•Clinically indicated for an intra-arterial procedure involving access through the common femoral artery and conducted through an access sheath size of between 6F and 7F inclusive.

Exclusion Criteria

•Patients with known allergy to any of the materials used in the device.
•Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than one year.
•Evidence of systemic bacterial or cutaneous infection, including groin infection.
•Patients suffering with definitive or potential coagulopathy or platelet count \<100,000./µl
•Use of systemic thrombolytic agents within 24 hours prior to or during the catheterization procedure which cause the concentration of fibrinogen to be \< 100 mg/dl or if post-thrombolytic fibrinogen (in case of thrombolysis within 24 hours or intra-procedural) cannot be measured.
•Patients in whom an introducer sheath smaller than 6F or greater than 7F have been used.
•Currently participating in another investigational device or drug study.
•Patients with severe claudication, iliac or femoral artery diameter stenosis greater than 50%, or previous bypass surgery or stent placement in the vicinity of the access site.
•If puncture site is via a vascular graft.
•If a palpable haematoma is observed during the procedure.

Outcomes

Primary Outcomes

The Primary Safety Endpoint Will be the Combined Rate of Major Complications With in 30 +/- 7 Days Following the Percutaneous Coronary Intervention (PCI) Procedure.

Time Frame: With in the first 30 days +/- 7 days following the procedure

rate of major complications with in 30 +/- 7 days following the PCI procedure.

The Primary Effectiveness Endpoint Will be Time to Hemostasis (TTH)

Time Frame: With in the first 30 days +/- 7 days following the procedure

Time to hemostasis

Secondary Outcomes

The Secondary Safety Endpoint Will be the Combined Rate of Minor Complications With in 30 +/- 7 Days Following Procedure.(With in the first 30 days +/- 7 days following the procedure)
Time to Ambulation(With in the first 30 days +/- 7 days following the procedure)
Procedure Success(30 days +/- 7 days)
Device Success(30 days +/- 7 days)
Time to Discharge-ability(30 days +/- 7 days)