Arterial Closure vs Direct Compression for Hemostasis After PCI - The ACDC Trial

NCT00264264 | Completed

• 1 other identifier: AC-101
• Study Type: interventional
• Target: 572
• Locations: 1 country
• Sites: 1

Brief Summary

Hemostasis at the arterial puncture site after percutaneous coronary interventions is achieved by either placement of a puncture closure device or by delaying sheath removal for hours to allow normalization of heparin induced anticoagulation. Both of these methods are far from ideal. Delayed sheath removal poses a risk of recurrent bleeding, hematoma formation and results in decreased patient mobility while the safety of closure devices has been called into question by several recent reports. Due to the lack of definitive data, the arterial access site management varies considerably between physicians and among institutions. The proposed study will evaluate the safety and efficacy of arterial closure devices to achieve hemostasis compared with immediate sheath removal after protamine administration followed by direct compression after percutaneous coronary intervention procedures.

Conditions

Coronary Angioplasty; Coronary Artery Disease

Keywords

Closure device; Stenting; Percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• A composite of major vascular complications (device failure, bleeding, hematoma, infection, pseudoaneurysm, AV fistula and vascular repair)

Secondary Outcomes (6)

• Time to hemostasis

• Ambulation time

• Quality of life

• Composite of minor vascular complication (bleeding, repeat compression, failure to ambulate per protocol),

• Post procedural infarction

Study Arms (2)

Direct Compression

ACTIVE COMPARATOR

Procedure: Direct Compression

Closure Device

ACTIVE COMPARATOR

Procedure: Closure Device

Interventions

Closure Device PROCEDURE

Closure Device

Direct Compression PROCEDURE

Direct Compression

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective PCI procedures. Femoral artery anatomy favorable for the placement of a closure device Planned use of clopidogrel and platelet glycoprotein IIb/IIIa antagonist

You may not qualify if:

• Emergency PCI End stage renal disease Hemoglobin level \< 100g/l Fish Allergy. Known allergy to Protamine. Use of low molecular weight heparin within last 12 hours. Prior closure device use within 90 days. Symptomatic peripheral vascular disease. Femoral artery calcification on fluoroscopy. Arterial puncture of the superficial femoral artery. Double wall puncture (puncture of anterior \& posterior wall of femoral artery). Placement of intra aortic balloon pump. Placement of a femoral venous sheath. Coronary dissection, thrombus or perforation not resolved by the end of case

Sponsors & Collaborators

• Unity Health Toronto: lead
• University of Toronto: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Vascular Closure Devices

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Asim Cheema, MD, PhD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2005
• First Posted: December 12, 2005
• Study Start: July 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 16, 2013

Record last verified: 2013-05

Locations

CA (1)