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The StarClose Vascular Closure System: interventional results from the CLIP study
J B Hermiller1, C Simonton, T Hinohara
1St. Vincent's Hospital, Indianapolis, Indiana, USA.
Summary
The StarClose Vascular Closure System is as safe as manual compression for femoral artery closure after percutaneous procedures. It significantly speeds up hemostasis, ambulation, and discharge.
Area of Science:
- Cardiovascular Interventions
- Medical Device Technology
- Clinical Trial Research
Background:
- The StarClose Vascular Closure System utilizes a nitinol clip for extravascular closure of arteriotomies.
- It is designed for femoral access site closure following catheterization procedures.
Purpose of the Study:
- To evaluate the safety and efficacy of the StarClose device in patients undergoing diagnostic and interventional catheterization.
- To compare StarClose to standard manual compression for arteriotomy closure.
Main Methods:
- A randomized trial involving 596 subjects across 17 U.S. sites.
- 483 subjects were randomized 2:1 to StarClose or manual compression.
- Primary endpoints included major vascular complications (safety) and time to hemostasis (efficacy).
Main Results:
- Major vascular complications were similar between StarClose (1.1%) and manual compression (1.1%) groups.
- StarClose showed a trend towards fewer minor complications (4.3% vs. 9.9%) and no pseudoaneurysms or fistulas.
- Procedural success rates were high for both groups (100% diagnostic, 98.9% interventional).
Conclusions:
- The StarClose Vascular Closure System is noninferior to manual compression for major vascular events in percutaneous interventional procedures.
- StarClose significantly reduced time to hemostasis, ambulation, and dischargeability compared to manual compression.
