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

June 8, 2016 updated by: Deutsches Herzzentrum Muenchen
Are novel vascular closure devices noninferior to manual compression regarding access site complications after coronary angiography?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

4524

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 80636
        • Deutsches Herzzentrum Muenchen
      • Munich, Germany, 81675
        • Klinikum Rechts der Isar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to hemostasis, from sheath removal to complete hemostasis
Time Frame: 30 days
30 days
Device deployment failure
Time Frame: 30 days
30 days
Need for repeated manual compression after end of closure procedure
Time Frame: 30 days
30 days
Cost-benefit Analysis
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Investigators

  • Principal Investigator: Maryam Linhardt, MD, Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

July 5, 2011

First Submitted That Met QC Criteria

July 6, 2011

First Posted (Estimate)

July 8, 2011

Study Record Updates

Last Update Posted (Estimate)

June 10, 2016

Last Update Submitted That Met QC Criteria

June 8, 2016

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE IDE No. PCD00111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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