Clinical Investigation for Safety and Efficacy Study of CELT ACD (Arterial ClosureDevice)

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiac Disease, Coronary Artery Disease

Intervention / Treatment
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* Device: CELT ACD


Participation Criteria
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Eligibility Criteria
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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. Patients in whom there is any indication that puncture has been made in the profunda femorals artery or superficial femoral artery, or adjacent to the bifurcation. Patients with a common femoral artery lumen diameter of less than 5 mm. Patients that have any amputation from an access site limb. Patients that have undergone a percutaneous procedure using a vascular closure device for hemostasis within the previous 30 days or using manual/mechanical pressure for hemostasis within the prior 30 days in the same leg. Patients with a systolic blood pressure reading below 90 mmHg. Patients with an active haematoma, arteriovenous fistula, or pseudoaneurysm. Patients with a very superficial artery where the depth from skin to the artery surface at the access site is less than 4 mm. Morbidly obese patients (Body Mass Index >35kg/m2). Patients with a stent less than or equal to 1 cm of the puncture site that would interfere with placement of the device implant. Patient is know or suspected to be pregnant, or is lactating. Patients in whom there has been an antegrade puncture. Patients in whom there has been difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial wall puncture. Patients who have undergone prior or recent use of an intra-aortic balloon pump through the arterial access site. Patients with uncontrolled hypertension (BP greater than or equal to 180/110mmHg) at time of vascular closure Patients with acute ST-elevation myocardial infarction less than or equal to 48hours before catheterization procedure. Patients with cardiogenic shock (hemodynamic instability requiring intravenous medication or mechanical support) experienced during or immediately post-catheterization. Patients who are unable to ambulate at baseline. Patients known to require an extended hospitalization (e.g. patient is undergoing cardiac surgery). Patient has already participated in the trial. Patient is unavailable for follow up. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CELT ACD device<br>The CELT ACD device is a vascular closure device. | Device: CELT ACD<br>* The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous intervention procedure using a 6F procedural sheath.<br>|
| No Intervention: Manual Compression<br>Manual Compression | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Safety Endpoint Will be the Combined Rate of Major Complications With in 30 +/- 7 Days Following the Percutaneous Coronary Intervention (PCI) Procedure. | rate of major complications with in 30 +/- 7 days following the PCI procedure. | With in the first 30 days +/- 7 days following the procedure | 
| The Primary Effectiveness Endpoint Will be Time to Hemostasis (TTH) | Time to hemostasis | With in the first 30 days +/- 7 days following the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Secondary Safety Endpoint Will be the Combined Rate of Minor Complications With in 30 +/- 7 Days Following Procedure. | 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 | Time to Ambulation (TTA) is defined as the time elapsed between sheath removal and time when the patient stands and walk 6m (20ft) without re-bleeding. | With in the first 30 days +/- 7 days following the procedure | 
| Time to Discharge-ability | Time to discharge-ability | 30 days +/- 7 days | 
| Procedure Success | Procedure Success 30 days +/- 7 days | 30 days +/- 7 days | 
| Device Success | Device Success (DS) is defined as the successful deployment of the Celt ACD device with the attainment of haemostasis and only assessed in the Celt ACD arm of the study. | 30 days +/- 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemostasis., Percutaneous coronary interventions., Closure Device