Instrumental Sealing of Arterial Puncture Site Closure Device Versus Manual Compression Trial
ISAR-CLOSURE
1 other identifier
interventional
4,524
1 country
2
Brief Summary
Are novel vascular closure devices noninferior to manual compression regarding access site complications after coronary angiography?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 coronary-artery-disease
Started Jul 2011
Typical duration for phase_4 coronary-artery-disease
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 5, 2011
CompletedFirst Posted
Study publicly available on registry
July 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJune 10, 2016
July 1, 2014
3 years
July 5, 2011
June 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite of arterial access related complications
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
30 days
Secondary Outcomes (4)
Time to hemostasis, from sheath removal to complete hemostasis
30 days
Device deployment failure
30 days
Need for repeated manual compression after end of closure procedure
30 days
Cost-benefit Analysis
30 days
Study Arms (3)
FemoSeal®
EXPERIMENTALDevice: FemoSeal®
ExoSeal®
EXPERIMENTALDevice: ExoSeal®
Manual compression
ACTIVE COMPARATOROther: Manual compression
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Deutsches Herzzentrum Muenchen
Munich, 80636, Germany
Klinikum rechts der Isar
Munich, 81675, Germany
Related Publications (3)
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.
PMID: 25399273BACKGROUNDGewalt 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.
PMID: 30354782DERIVEDXhepa 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.
PMID: 24952057DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maryam Linhardt, MD
Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2011
First Posted
July 8, 2011
Study Start
July 1, 2011
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
June 10, 2016
Record last verified: 2014-07