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

German Heart Center Munich

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Other: Manual compression; Device: ExoSeal®; Device: FemoSeal®

Study type: Interventional

Funder types: Other

Identifiers

NCT01389375

GE IDE No. PCD00111

Details and patient eligibility

About

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

Full 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.

Enrollment: 4,524 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,524 participants in 3 patient groups

FemoSeal®

Experimental group

Description:

Device: FemoSeal®

Treatment:

Device: FemoSeal®

ExoSeal®

Experimental group

Description:

Device: ExoSeal®

Treatment:

Device: ExoSeal®

Manual compression

Active Comparator group

Description:

Other: Manual compression

Treatment:

Other: Manual compression