Instrumental Sealing of Arterial Puncture Site Closure Device Versus Manual Compression Trial
NCT ID: NCT01389375
Last Updated: 2016-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
4524 participants
INTERVENTIONAL
2011-07-31
2014-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FemoSeal®
Device: FemoSeal®
FemoSeal®
Closure device for femoral artery access closure
ExoSeal®
Device: ExoSeal®
ExoSeal®
Closure device for femoral artery access closure
Manual compression
Other: Manual compression
Manual compression
Conventional manual compression
Interventions
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FemoSeal®
Closure device for femoral artery access closure
ExoSeal®
Closure device for femoral artery access closure
Manual compression
Conventional manual compression
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing femoral access coronary angiography
* Access only with 6 F sheath
* Patient must be competent for providing informed written consent
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Deutsches Herzzentrum Muenchen
OTHER
Responsible Party
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Principal Investigators
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Maryam Linhardt, MD
Role: PRINCIPAL_INVESTIGATOR
Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
Locations
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Deutsches Herzzentrum Muenchen
Munich, , Germany
Klinikum rechts der Isar
Munich, , Germany
Countries
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References
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Schulz-Schupke S, Helde S, Gewalt S, Ibrahim T, Linhardt M, Haas K, Hoppe K, Bottiger C, Groha P, Bradaric C, Schmidt R, Bott-Flugel L, Ott I, Goedel J, Byrne RA, Schneider S, Burgdorf C, Morath T, Kufner S, Joner M, Cassese S, Hoppmann P, Hengstenberg C, Pache J, Fusaro M, Massberg S, Mehilli J, Schunkert H, Laugwitz KL, Kastrati A; Instrumental Sealing of Arterial Puncture Site-CLOSURE Device vs Manual Compression (ISAR-CLOSURE) Trial Investigators. Comparison of vascular closure devices vs manual compression after femoral artery puncture: the ISAR-CLOSURE randomized clinical trial. JAMA. 2014 Nov 19;312(19):1981-7. doi: 10.1001/jama.2014.15305.
Gewalt SM, Helde SM, Ibrahim T, Mayer K, Schmidt R, Bott-Flugel L, Hoppe K, Ott I, Hieber J, Morath T, Byrne RA, Kufner S, Cassese S, Hoppmann P, Fusaro M, Schunkert H, Laugwitz KL, Kastrati A, Schupke S; Instrumental Sealing of Arterial Puncture Site-CLOSURE Device Versus Manual Compression (ISAR-CLOSURE) Trial Investigators. Comparison of Vascular Closure Devices Versus Manual Compression After Femoral Artery Puncture in Women. Circ Cardiovasc Interv. 2018 Aug;11(8):e006074. doi: 10.1161/CIRCINTERVENTIONS.117.006074.
Xhepa E, Byrne RA, Schulz S, Helde S, Gewalt S, Cassese S, Linhardt M, Ibrahim T, Mehilli J, Hoppe K, Grupp K, Kufner S, Bottiger C, Hoppmann P, Burgdorf C, Fusaro M, Ott I, Schneider S, Hengstenberg C, Schunkert H, Laugwitz KL, Kastrati A; ISAR-CLOSURE investigators. Rationale and design of a randomised clinical trial comparing vascular closure device and manual compression to achieve haemostasis after diagnostic coronary angiography: the Instrumental Sealing of ARterial puncture site - CLOSURE device versus manual compression (ISAR-CLOSURE) trial. EuroIntervention. 2014 Jun;10(2):198-203. doi: 10.4244/EIJV10I2A33.
Other Identifiers
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GE IDE No. PCD00111
Identifier Type: -
Identifier Source: org_study_id
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