Clinical Investigation for Safety and Efficacy Study of CELT ACD Arterial Closure Device
This study is currently recruiting participants.
Verified October 2012 by Vasorum Ltd
Information provided by (Responsible Party):
First received: May 16, 2012
Last updated: November 28, 2013
Last verified: October 2012
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 coronary intervention (PCI) procedure using either a 6F or 7F procedural sheath.
Coronary Artery Disease
Device: CELT ACD
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
||Clinical Investigation Plan for Safety and Efficacy Study of Arterial Closure Device (CELT ACD). Clinical Investigation Plan No.: CIP-TS-003
Primary Outcome Measures:
- The primary safety endpoint will be the combined rate of major complications with in 30 +/- 7 days following the PCI procedure. [ Time Frame: With in the first 30 days +/- 7 days following the procedure ] [ Designated as safety issue: Yes ]
- The primary effectiveness endpoint will be time to hemostasis (TTH) [ Time Frame: With in the first 30 days +/- 7 days following the procedure ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
- The secondary effectiveness endpoint will be time to ambulation, time to discharge-ability, procedure success and device success. [ Time Frame: With in the first 30 days +/- 7 days following the procedure ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2014 (Final data collection date for primary outcome measure)
Experimental: CELT ACD device
The CELT ACD device is a vascular closure device.
Device: CELT ACD
The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath.
No Intervention: Manual Compression
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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 catheterisation 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-catherization.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01600482
|Cooper University Hospital
|Camden, New Jersey, United States, 08103 |
|Contact: Zoltan Turi, Dr 856-342-3488 Turi-Zoltan@CooperHealth.edu |
|Principal Investigator: Zoltan Turi, Dr |
|New York Presbyterian Hospital
|New York,, New York, United States, 10021 |
|Contact: Shing Chiu Wong, Dr 212-746-4644 firstname.lastname@example.org |
|Principal Investigator: Shing Chiu Wong, Dr |
|Charite Campus Mitte
|Berlin, Germany, 10117 |
|Contact: Michael Laule, Dr +49 30 450613103 email@example.com |
|Principal Investigator: Michael Laule, Dr |
|Galway University Hosptial
|Galway, Ireland |
|Contact: James Crowley, Dr 00-353-91-542190 |
|Principal Investigator: James Crowley, Dr |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 16, 2012
||November 28, 2013
||United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by Vasorum Ltd:
Percutaneous coronary interventions.
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Coronary Artery Disease
Arterial Occlusive Diseases