ANGIO-Seal™ or Manual Compression After Coronary Intervention Evaluation
| ISRCTN | ISRCTN22655249 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22655249 |
| Protocol serial number | NTR569; 9051 |
| Sponsor | Diagram BV (Netherlands) |
| Funder | St. Jude Medical Nederland BV (Netherlands) |
- Submission date
- 14/02/2006
- Registration date
- 14/02/2006
- Last edited
- 26/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J. Klijn
Scientific
Scientific
Diagram B.V. Zwolle
Van Nahuysplein 6
Zwolle
8011 NB
Netherlands
| Phone | +31 (0)38 4262997 |
|---|---|
| j.klijn@diagram-zwolle.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single center prospective randomised open label active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Angiocare |
| Study objectives | It is assumed that the incidence of the primary endpoint after manual compression will be 7% and after the Angio-Seal™ 2%. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Percutaneous Coronary Intervention (PCI) |
| Intervention | Manual compression or Angio-Seal™ closure device of arteria femoralis after PCI. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Incidence of: |
| Key secondary outcome measure(s) |
The decrease of hemoglobin 1 day after inclusion. |
| Completion date | 01/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 614 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 19/01/2006 |
| Date of final enrolment | 01/02/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Diagram B.V. Zwolle
Zwolle
8011 NB
Netherlands
8011 NB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
