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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01600482
First Posted: May 17, 2012
Last Update Posted: August 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vasorum Ltd
  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 intervention (PCI) procedure using a 6F sheath.

Condition Intervention
Cardiac Disease Coronary Artery Disease Device: CELT ACD

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Clinical Investigation Plan (CIP) for Safety and Efficacy Study of Arterial Closure Device (CELT ACD). Clinical Investigation Plan No.: CIP-TS-003

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 Percutaneous Coronary Intervention (PCI) Procedure. [ Time Frame: With in the first 30 days +/- 7 days following the procedure ]
    rate of major complications with in 30 +/- 7 days following the PCI procedure.

  • The Primary Effectiveness Endpoint Will be Time to Hemostasis (TTH) [ Time Frame: With in the first 30 days +/- 7 days following the procedure ]
    Time to hemostasis


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 ]
    combined rate of minor complications with in 30 +/- 7 days following procedure.

  • Time to Ambulation [ Time Frame: With in the first 30 days +/- 7 days following the procedure ]
    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.

  • Time to Discharge-ability [ Time Frame: 30 days +/- 7 days ]
    Time to discharge-ability

  • Procedure Success [ Time Frame: 30 days +/- 7 days ]
    Procedure Success 30 days +/- 7 days

  • Device Success [ Time Frame: 30 days +/- 7 days ]
    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.


Enrollment: 241
Study Start Date: May 2012
Study Completion Date: February 2016
Primary Completion Date: February 2016 (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 intervention procedure using a 6F procedural sheath.
No Intervention: Manual Compression
Manual Compression

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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.
  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-catheterization.
  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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01600482


Locations
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10021
Germany
Städtische Kliniken Neuss - Lukaskrankenhaus - GmbH
Preußenstr. 84,41464 Neuss, Neuss, Germany, 41464 Neuss
Charite Campus Mitte
Berlin, Germany, 10117
Ireland
Galway University Hosptial
Galway, Ireland
Sponsors and Collaborators
Vasorum Ltd
  More Information

Responsible Party: Vasorum Ltd
ClinicalTrials.gov Identifier: NCT01600482     History of Changes
Other Study ID Numbers: CIP-TS-003
First Submitted: May 16, 2012
First Posted: May 17, 2012
Results First Submitted: May 16, 2017
Results First Posted: August 23, 2017
Last Update Posted: August 23, 2017
Last Verified: July 2017

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