CELT ACD device for Coronary Artery Disease

N/A

Waitlist Available

Research Sponsored by Vasorum Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days +/- 7 days

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Coronary Artery Disease
Cardiovascular Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ with in the first 30 days +/- 7 days following the procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~with in the first 30 days +/- 7 days following the procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and with in the first 30 days +/- 7 days following the procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

Secondary study objectives

Device Success

Procedure Success

The Secondary Safety Endpoint Will be the Combined Rate of Minor Complications With in 30 +/- 7 Days Following Procedure.

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