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

Coronary Artery Disease Clinical Trial

Official title:

Clinical Investigation Plan for Safety and Efficacy Study of Arterial Closure Device (CELT ACD). Clinical Investigation Plan No.: CIP-TS-003

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600482
• Other study ID #: CIP-TS-003
• Status: Completed
• Phase: N/A
• First received: May 16, 2012
• Last updated: April 27, 2016
• Start date: May 2012
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: Vasorum Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiac Disease
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Vasorum Ltd

Countries where clinical trial is conducted

United States,  Germany,  Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary safety endpoint will be the combined rate of major complications with in 30 +/- 7 days following the PCI procedure.		With in the first 30 days +/- 7 days following the procedure	Yes
Primary	The primary effectiveness endpoint will be time to hemostasis (TTH)		With in the first 30 days +/- 7 days following the procedure	No
Secondary	The secondary safety endpoint will be the combined rate of minor complications with in 30 +/- 7 days following procedure.		With in the first 30 days +/- 7 days following the procedure	Yes
Secondary	The secondary effectiveness endpoint will be time to ambulation, time to discharge-ability, procedure success and device success.		With in the first 30 days +/- 7 days following the procedure	No