Star-Close Versus Angio-Seal for Femoral Artery Hemostasis (NCT00590356) | Clinical Trial Compass
WithdrawnPhase 4
Star-Close Versus Angio-Seal for Femoral Artery Hemostasis
South Korea0Started 2007-03
Plain-language summary
This study was designed to evaluate the efficacy and safety of Starclose (Abbott Vascular Devices) for femoral access site closure in patients undergoing PCI compared to Angio-Seal STS Plus (St. Jude Medical).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The patient must be at least 18 years of age.
* Patients with appropriate arterial puncture in the common femoral artery eligible for percutaneous closure device deployment Patients undergoing PCI (only 7F sheath)
* Patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion Criteria:
* Uncontrolled hypertension
* Severe peripheral vascular disease
* Severe femoral artery tortousity and calcification
* Severe obesity (BMI \> 35)
* History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions
* Current known current platelet count \<100,000 cells/mm3 or Hgb \<10 g/dL.
* Patients with cardiogenic shock
* Acute MI patients within symptom onset \< 12 hours needing primary angioplasty
What they're measuring
1
Composite of major vascular complications necessitating surgical or percutaneous repair.