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Clinical experience with a circumferential clip-based vascular closure device in diagnostic catheterization
James Hermiller1, Charles Simonton, Tom Hinohara
1St. Vincent Hospital and Health Center, Indianapolis, Indiana, USA.
The Journal of Invasive Cardiology
|October 6, 2005
Summary
The StarClose Vascular Closure System effectively closes femoral arteriotomies with no major complications, significantly reducing closure time compared to manual compression.
Area of Science:
- Vascular Surgery
- Medical Devices
- Interventional Cardiology
Background:
- The StarClose Vascular Closure System uses a nitinol clip for extravascular closure of femoral arteriotomies.
- It is an investigational device in the US, with CE Mark approval.
Purpose of the Study:
- To compare the StarClose system with manual compression for vascular closure.
- To evaluate major vascular complications and time-to-hemostasis in diagnostic angiography patients.
Main Methods:
- A prospective, randomized, multicenter trial (CLIP study) with a noninferiority design.
- 596 subjects enrolled; this report focuses on 208 who underwent diagnostic angiography.
- Primary endpoints: major vascular complications and time-to-hemostasis; 30-day clinical follow-up.
Main Results:
- No major vascular complications in either group (StarClose n=136, manual compression n=72).
- Minor complications: 2.2% StarClose vs. 1.4% manual compression (p=1.00).
- StarClose significantly reduced mean time-to-hemostasis (1.46 vs. 15.47 min, p<0.001) and time-to-ambulation (163 vs. 269 min, p<0.001).
Conclusions:
- StarClose Vascular Closure System is noninferior to manual compression for arteriotomy closure safety.
- The device demonstrates significant efficacy in reducing hemostasis and ambulation times.