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

NCT01600482 | Completed Results DMC

• 1 other identifier: CIP-TS-003
• Study Type: interventional
• Target: 241
• Locations: 3 countries
• Sites: 5

Brief 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 intervention (PCI) procedure using a 6F sheath.

Conditions

Cardiac Disease; Coronary Artery Disease

Keywords

Hemostasis.; Percutaneous coronary interventions.; Closure Device

Outcome Measures

Primary Outcomes (2)

• The Primary Safety Endpoint Will be the Combined Rate of Major Complications With in 30 +/- 7 Days Following the Percutaneous Coronary Intervention (PCI) Procedure.

  rate of major complications with in 30 +/- 7 days following the PCI procedure.

  With in the first 30 days +/- 7 days following the procedure

• The Primary Effectiveness Endpoint Will be Time to Hemostasis (TTH)

  Time to hemostasis

  With in the first 30 days +/- 7 days following the procedure

Secondary Outcomes (5)

• 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

• Time to Ambulation

  With in the first 30 days +/- 7 days following the procedure

• Time to Discharge-ability

  30 days +/- 7 days

• Procedure Success

  30 days +/- 7 days

• Device Success

  30 days +/- 7 days

Study Arms (2)

CELT ACD device

EXPERIMENTAL

The CELT ACD device is a vascular closure device.

Device: CELT ACD

Manual Compression

NO INTERVENTION

Manual Compression

Interventions

CELT ACD DEVICE

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.

CELT ACD device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vasorum Ltd: lead

Study Sites (5)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

New York Presbyterian Hospital

New York, New York, 10021, United States

Location

Städtische Kliniken Neuss - Lukaskrankenhaus - GmbH

Preußenstr. 84,41464 Neuss, Neuss, 41464 Neuss, Germany

Location

Charite Campus Mitte

Berlin, 10117, Germany

Location

Galway University Hosptial

Galway, Ireland, Ireland

Location

Related Publications (1)

• Wong SC, Laule M, Turi Z, Sanad W, Crowley J, Degen H, Bennett K, Coleman JE, Bergman G. A multicenter randomized trial comparing the effectiveness and safety of a novel vascular closure device to manual compression in anticoagulated patients undergoing percutaneous transfemoral procedures: The CELT ACD trial. Catheter Cardiovasc Interv. 2017 Nov 1;90(5):756-765. doi: 10.1002/ccd.26991. Epub 2017 Mar 15.

  PMID: 28296003 DERIVED

MeSH Terms

Conditions

Heart Diseases; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Dr James Coleman
• Organization: Vasorum Ltd

jcoleman@vasorum.ie

00 353 1 4035460

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2012
• First Posted: May 17, 2012
• Study Start: May 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: August 23, 2017
• Results First Posted: August 23, 2017

Record last verified: 2017-07

Locations

IE (1); DE (2); US (2)