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

Completed · Not applicable

Conditions studied: Cardiac Disease, Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT01600482

Run by

Vasorum Ltd

People needed

241

Starts

2012-05-01

Expected to finish

2016-02-01

Last updated by the study team

2017-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cooper University Hospital — Camden, New Jersey, United States
• New York Presbyterian Hospital — New York, New York, United States
• Städtische Kliniken Neuss - Lukaskrankenhaus - GmbH — Preußenstr. 84,41464 Neuss, Neuss, Germany
• Charite Campus Mitte — Berlin, Germany
• Galway University Hosptial — Galway, Ireland, Ireland

Full record on ClinicalTrials.gov

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