ANGIO-Seal™ or Manual Compression After Coronary Intervention Evaluation
| ISRCTN | ISRCTN22655249 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22655249 |
| Secondary identifying numbers | NTR569; 9051 |
- 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
| Study design | Single center prospective randomised open label active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 19/01/2006 |
| Completion date | 01/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
Sponsor information
Diagram BV (Netherlands)
Industry
Industry
van Nahuysplein 6
Zwolle
8011 NB
Netherlands
| Website | http://www.diagram-zwolle.nl |
|---|---|
"ROR" |
https://ror.org/03rhyyh86 |
Funders
Funder type
Industry
St. Jude Medical Nederland BV (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
