Patients undergoing PCI, who have a high risk of bleeding
Conditions
Interventions
Manual compression or Angio-Seal closure device of arteria femoralis after PCI.
Sponsors
Diagram B.V.
van Nahuysplein 6
8011 NB Zwolle
Eligibility
Inclusion criteria
Inclusion criteria: A. Percutaneous Coronary Intervention via the femoral artery, with either B or C; B. At least the following medication: 1. Aspirin 2. Unfractionated Heparin 3. Clopidogrel 600mg pre-loading dose 4. Glycoprotein 2B/3A inhibitor; C. PCI within 4 hours after administration of thrombolysis.
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| The decrease of hemoglobin, 1 day after inclusion. | — |
Contacts
Public ContactJ. Klijn
Diagram B.V. Zwolle Dokter Stolteweg 96
Outcome results
None listed