Condition category
Surgery
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
26/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J. Klijn

ORCID ID

Contact details

Diagram B.V. Zwolle
Van Nahuysplein 6
Zwolle
8011 NB
Netherlands
+31 (0)38 4262997
j.klijn@diagram-zwolle.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR569; 9051

Study information

Scientific title

Acronym

Angiocare

Study hypothesis

It is assumed that the incidence of the primary endpoint after manual compression will be 7% and after the Angio-Seal™ 2%.

Ethics approval

Received from local medical ethics committee

Study design

Single center prospective randomised open label active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Percutaneous Coronary Intervention (PCI)

Intervention

Manual compression or Angio-Seal™ closure device of arteria femoralis after PCI.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Incidence of:
1. Severe hematoma at the puncture site or groin bleeding resulting in prolonged hospital stay or transfusion
2. Arteriovenous fistula formation at the puncture site and/or surgical intervention at the puncture site

Secondary outcome measures

The decrease of hemoglobin 1 day after inclusion.

Overall trial start date

19/01/2006

Overall trial end date

01/02/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Percutaneous Coronary Intervention via the femoral artery, with either B or C
2. At least the following medication
2.1. Aspirin
2.2. Unfractionated Heparin
2.3. Clopidogrel 600 mg pre-loading dose
2.4. Glycoprotein 2B/3A inhibitor
3. Percutaneous coronary intervention (PCI) within 4 hours after administration of thrombolysis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

614

Participant exclusion criteria

1. Age <18 years
2. Serious comorbidity such as cancer
3. Advanced cerebrovascular disease
4. Unwilling or unable to sign the consent form for participation
5. Females of childbearing age not using medically prescribed contraceptives
6. Unsuitable access site (severe PVD, poor location)

Recruitment start date

19/01/2006

Recruitment end date

01/02/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Diagram B.V. Zwolle
Zwolle
8011 NB
Netherlands

Sponsor information

Organisation

Diagram BV (Netherlands)

Sponsor details

van Nahuysplein 6
Zwolle
8011 NB
Netherlands

Sponsor type

Industry

Website

http://www.diagram-zwolle.nl

Funders

Funder type

Industry

Funder name

St. Jude Medical Nederland BV (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes