Clinical Investigation for Safety and Efficacy Study of CELT ACD Arterial Closure Device

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Vasorum Ltd
Sponsor:
Information provided by (Responsible Party):
Vasorum Ltd
ClinicalTrials.gov Identifier:
NCT01600482
First received: May 16, 2012
Last updated: November 28, 2013
Last verified: October 2012
  Purpose

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.


Condition Intervention
Cardiac Disease
Coronary Artery Disease
Device: CELT ACD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Clinical Investigation Plan for Safety and Efficacy Study of Arterial Closure Device (CELT ACD). Clinical Investigation Plan No.: CIP-TS-003

Resource links provided by NLM:


Further study details as provided by Vasorum Ltd:

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: 207
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Manual Compression

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Over 18 years of age.
  2. Each patient, or his or her guardian or legal representative, is willing to give informed consent.
  3. 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:

  1. Patients with known allergy to any of the materials used in the device.
  2. Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than one year.
  3. Evidence of systemic bacterial or cutaneous infection, including groin infection.
  4. Patients suffering with definitive or potential coagulopathy or platelet count <100,000./µl
  5. 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.
  6. Patients in whom an introducer sheath smaller than 6F or greater than 7F have been used.
  7. Currently participating in another investigational device or drug study.
  8. 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.
  9. If puncture site is via a vascular graft.
  10. If a palpable haematoma is observed during the procedure.
  11. 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.
  12. Patients with a common femoral artery lumen diameter of less than 5 mm.
  13. Patients that have any amputation from an access site limb.
  14. 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.
  15. Patients with a systolic blood pressure reading below 90 mmHg.
  16. Patients with an active haematoma, arteriovenous fistula, or pseudoaneurysm.
  17. Patients with a very superficial artery where the depth from skin to the artery surface at the access site is less than 4 mm.
  18. Morbidly obese patients (Body Mass Index >35kg/m2).
  19. Patients with a stent less than or equal to 1 cm of the puncture site that would interfere with placement of the device implant.
  20. Patient is know or suspected to be pregnant, or is lactating.
  21. Patients in whom there has been an antegrade puncture.
  22. Patients in whom there has been difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial wall puncture.
  23. Patients who have undergone prior or recent use of an intra-aortic balloon pump through the arterial access site.
  24. Patients with uncontrolled hypertension (BP greater than or equal to 180/110mmHg) at time of vascular closure
  25. Patients with acute ST-elevation myocardial infarction less than or equal to 48hours before catheterization procedure.
  26. Patients with cardiogenic shock (hemodynamic instability requiring intravenous medication or mechanical support) experienced during or immediately post-catherization.
  27. Patients who are unable to ambulate at baseline.
  28. Patients known to require an extended hospitalization (e.g. patient is undergoing cardiac surgery).
  29. Patient has already participated in the trial.
  30. Patient is unavailable for follow up.

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01600482

Locations
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Zoltan Turi, Dr    856-342-3488    Turi-Zoltan@CooperHealth.edu   
Principal Investigator: Zoltan Turi, Dr         
United States, New York
New York Presbyterian Hospital Recruiting
New York,, New York, United States, 10021
Contact: Shing Chiu Wong, Dr    212-746-4644    scwong@med.cornell.edu   
Principal Investigator: Shing Chiu Wong, Dr         
Germany
Charite Campus Mitte Recruiting
Berlin, Germany, 10117
Contact: Michael Laule, Dr    +49 30 450613103    michael.laule@charite.de   
Principal Investigator: Michael Laule, Dr         
Ireland
Galway University Hosptial Recruiting
Galway, Ireland
Contact: James Crowley, Dr    00-353-91-542190      
Principal Investigator: James Crowley, Dr         
Sponsors and Collaborators
Vasorum Ltd
  More Information

No publications provided

Responsible Party: Vasorum Ltd
ClinicalTrials.gov Identifier: NCT01600482     History of Changes
Other Study ID Numbers: CIP-TS-003
Study First Received: May 16, 2012
Last Updated: November 28, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Vasorum Ltd:
Hemostasis.
Percutaneous coronary interventions.
Closure Device

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014