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Instrumental Sealing of Arterial Puncture Site Closure Device Versus Manual Compression Trial (ISAR-CLOSURE)

This study is currently recruiting participants.
Verified May 2012 by Deutsches Herzzentrum Muenchen
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01389375
First received: July 5, 2011
Last updated: May 7, 2012
Last verified: May 2012
History of Changes
  Purpose

Are novel vascular closure devices noninferior to manual compression regarding access site complications after coronary angiography?


Condition Intervention Phase
Coronary Artery Disease
 Device: FemoSeal®
Device: ExoSeal®
Other: Manual compression
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Instrumental Sealing of Arterial Puncture Site Closure Device Versus Manual Compression Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Composite of arterial access related complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

    Composite of arterial access related complications, defined as the composite of:

    • Rate of ipsilateral groin hematomas with largest diameter exceeding 5 cm
    • Pseudoaneurysm
    • AV-Fistula
    • Major bleeding
    • Critical limb ischemia
    • Local infection
    • Surgical repair
    • Revascularisation


Secondary Outcome Measures:
  • Time to hemostasis, from sheath removal to complete hemostasis [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Device deployment failure [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Need for repeated manual compression after end of closure procedure [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Cost-benefit Analysis [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 4500
Study Start Date: July 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FemoSeal®
Device: FemoSeal®
 Device: FemoSeal®
Closure device for femoral artery access closure
Experimental: ExoSeal®
Device: ExoSeal®
 Device: ExoSeal®
Closure device for femoral artery access closure
Active Comparator: Manual compression
Other: Manual compression
 Other: Manual compression
Conventional manual compression

Detailed Description:

Vascular closure devices have been shown to be safe and effective in reducing the time to hemostasis and immobilization when compared to manual compression following coronary angiography. This effect is beneficial in patients presenting with chronic back pain, prostate enlargement, mental impairment or other disorders that preclude prolonged bed rest.

However, adequately powered large scale randomized trials with vascular closure devices remain a gap in the scientific literature.

This trial compares, in a randomised design two novel vascular closure devices (FemoSeal & ExoSeal) versus manual compression after coronary angiography. This study is aimed to investigate if novel vascular closure devices are noninferior to manual compression regarding access site complications.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient between 18 and 85 years of age
  • Patients undergoing femoral access coronary angiography
  • Access only with 6 F sheath
  • Patient must be competent for providing informed written consent

Exclusion Criteria:

  • Peripheral arterial occlusive disease
  • Prior peripheral artery surgery
  • Percutaneous coronary intervention
  • Femoral access device closure in last 30 days
  • Scheduled Coronary Angiography/Intervention within 90 days
  • Critical limb ischemic
  • Uncontrolled hypertension >220/110 mmHg
  • Coagulopathy (bleeding disorder)
  • Local infection
  • Common femoral artery lumen diameter < 5 mm
  • Allergy to absorbable suture
  • Autoimmune Disease
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389375

Contacts
Contact: Maryam Linhardt, MD +49 (0)89-1218-4566 ibrahimM@dhm.mhn.de
Contact: Tobias Koppara, MD Koppara@dhm.mhn.de

Locations
Germany
Deutsches Herzzentrum Muenchen Recruiting
Munich, Germany, 80636
Contact: Maryam Linhardt, MD     +49 (0)89-1218-4566     ibrahimM@dhm.mhn.de    
Contact: Tobias Koppara, MD         Koppara@dhm.mhn.de    
Principal Investigator: Maryam Linhardt, MD            
Klinikum rechts der Isar Recruiting
Munich, Germany, 81675
Contact: Tareq Ibrahim, MD         Ibrahim@dhm.mhn.de    
Contact: Tobias Koppara, MD         Koppara@dhm.mhn.de    
Principal Investigator: Tareq Ibrahim, MD            
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Principal Investigator: Maryam Linhardt, MD Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
  More Information

No publications provided

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01389375     History of Changes
Other Study ID Numbers: GE IDE No. PCD00111
Study First Received: July 5, 2011
Last Updated: May 7, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Deutsches Herzzentrum Muenchen:
Closure Device
Coronary Angiography

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 June 17, 2013