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

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ClinicalTrials.gov Identifier: NCT01389375
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

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

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: FemoSeal® Device: ExoSeal® Other: Manual compression Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4524 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Instrumental Sealing of Arterial Puncture Site Closure Device Versus Manual Compression Trial
Study Start Date : July 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Composite of arterial access related complications [ Time Frame: 30 days ]

    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 :
  1. Time to hemostasis, from sheath removal to complete hemostasis [ Time Frame: 30 days ]
  2. Device deployment failure [ Time Frame: 30 days ]
  3. Need for repeated manual compression after end of closure procedure [ Time Frame: 30 days ]
  4. Cost-benefit Analysis [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT01389375


Locations
Germany
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
Klinikum rechts der Isar
Munich, Germany, 81675
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Principal Investigator: Maryam Linhardt, MD Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01389375     History of Changes
Other Study ID Numbers: GE IDE No. PCD00111
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: July 2014

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