- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01600482
Clinical Investigation for Safety and Efficacy Study of CELT ACD (Arterial ClosureDevice)
July 24, 2017 updated by: Vasorum Ltd
Clinical Investigation Plan (CIP) for Safety and Efficacy Study of Arterial Closure Device (CELT ACD). Clinical Investigation Plan No.: CIP-TS-003
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
241
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany, 10117
- Charité Campus Mitte
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Neuss
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Preußenstr. 84,41464 Neuss, Neuss, Germany, 41464 Neuss
- Städtische Kliniken Neuss - Lukaskrankenhaus - GmbH
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Galway, Ireland
- Galway University Hosptial
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New Jersey
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Camden, New Jersey, United States, 08103
- Cooper University Hospital
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New York
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New York, New York, United States, 10021
- New York Presbyterian Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: CELT ACD device
The CELT ACD device is a vascular closure device.
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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.
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No Intervention: Manual Compression
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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rate of major complications with in 30 +/- 7 days following the PCI procedure.
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With in the first 30 days +/- 7 days following the procedure
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The Primary Effectiveness Endpoint Will be Time to Hemostasis (TTH)
Time Frame: With in the first 30 days +/- 7 days following the procedure
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Time to hemostasis
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With in the first 30 days +/- 7 days following the procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The Secondary Safety Endpoint Will be the Combined Rate of Minor Complications With in 30 +/- 7 Days Following Procedure.
Time Frame: With in the first 30 days +/- 7 days following the procedure
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combined rate of minor complications with in 30 +/- 7 days following procedure.
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With in the first 30 days +/- 7 days following the procedure
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Time to Ambulation
Time Frame: With in the first 30 days +/- 7 days following the procedure
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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.
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With in the first 30 days +/- 7 days following the procedure
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Time to Discharge-ability
Time Frame: 30 days +/- 7 days
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Time to discharge-ability
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30 days +/- 7 days
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Procedure Success
Time Frame: 30 days +/- 7 days
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Procedure Success 30 days +/- 7 days
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30 days +/- 7 days
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Device Success
Time Frame: 30 days +/- 7 days
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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.
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30 days +/- 7 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
May 16, 2012
First Submitted That Met QC Criteria
May 16, 2012
First Posted (Estimate)
May 17, 2012
Study Record Updates
Last Update Posted (Actual)
August 23, 2017
Last Update Submitted That Met QC Criteria
July 24, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIP-TS-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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