Clinical trial NCT01389375: Instrumental Sealing of Arterial Puncture Site Closure Device Versus Manual Compression Trial
Official title: Instrumental Sealing of Arterial Puncture Site Closure Device Versus Manual Compression Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Closure Device
Coronary Angiography
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2011-07-08
Enrollment: 4524
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Composite of arterial access related complications
timeFrame: 30 days
Secondary outcomes:
measure: Time to hemostasis, from sheath removal to complete hemostasis
timeFrame: 30 days
measure: Device deployment failure
timeFrame: 30 days
measure: Need for repeated manual compression after end of closure procedure
timeFrame: 30 days
measure: Cost-benefit Analysis
timeFrame: 30 days
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
city: Munich
country: Germany
facility: Klinikum rechts der Isar
Study officials:
affiliation: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
name: Maryam Linhardt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.