Ensure's Vascular Closure Device Speeds Hemostasis Trial - ECLIPSE

Apr 01, 2008
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Date Presented:
01/01/2008
Date Published:
01/01/2009
Date Updated:
04/01/2008
Original Posted Date:
04/01/2008
References

Description:

The goal of this trial was to evaluate vascular closure with the ExoSeal® plug (poly-glycolic acid) compared with manual pressure in patients undergoing diagnostic and interventional coronary/peripheral procedures.

Hypothesis:

The ExoSeal vascular closure device will shorten time to hemostasis.

Study Design

Patients Screened: 488
Patients Enrolled: 401
Mean Follow Up: 30 days
Mean Patient Age: 63 years
Female: 34

Patient Populations:

• Patients undergoing diagnostic and interventional coronary/peripheral procedures with a femoral 6 French sheath
• Ability to undergo emergent vascular surgery if a complication occurred
• Target vessel lumen diameter of at least 5 mm

Exclusions:

• Uncontrolled hypertension
• Body mass index >40 kg/m2
• Prior femoral vascular surgery
• Planned repeat arterial access
• Prior femoral artery closure in the last 30 days
• Calcified femoral artery

Primary Endpoints:

• Time to hemostasis and time to ambulation

• Composite of bleeding requiring transfusion, infection, or ischemia or injury requiring repair

Drug/Procedures Used:

Patients undergoing diagnostic and interventional coronary/peripheral procedures were randomized to the ExoSeal vascular closure device (n = 267) or manual pressure (n = 134).

Principal Findings:

Most of the procedures were coronary (approximately 90%), and 50% of all the procedures were interventional. The device was successfully used 89% of the time. For ExoSeal versus manual pressure, the time to hemostasis was 4.4 minutes versus 20.1 minutes (p < 0.0001), and time to ambulation was 2.5 hours versus 6.2 hours (p = 0.0028). There were no adverse events reported in either group. Re-bleeding was 5.3% in the ExoSeal group and 2.2% in the manual compression group (p = 0.20); hematoma >6 cm was 1.9% versus 0.7% (p = 0.67).

Interpretation:

The use of the ExoSeal vascular closure device reduces time to hemostasis and time to ambulation compared with manual pressure in patients undergoing both diagnostic and interventional procedures. There were nonsignificant increases in re-bleeding and large hematomas with the ExoSeal. Further research will need to determine the indication of this device compared with other commercially available closure devices. Also, the safety profile of this device will need to be carefully monitored, especially with regard to bleeding during interventional procedures.

References:

ECLIPSE Trial: Ensure's Vascular Closure Device Speeds Hemostasis. Presented by Dr. Shing-Chiu Wong at the SCAI-ACC i2 Summit/American College of Cardiology Annual Scientific Session, Chicago, IL, March/April 2008.

Wong SC, Bachinsky W, Cambier P, et al. A randomized comparison of a novel bioabsorbable vascular closure device versus manual compression in the achievement of hemostasis after percutaneous femoral procedures: the ECLIPSE (Ensure's Vascular Closure Device Speeds Hemostasis Trial). JACC Cardiovasc Interv. 2009 Aug;2(8):785-93.

Keywords: Walking, Glycolates, Hemostatic Techniques, Femoral Artery, Hematoma, Hemostasis, Peripheral Vascular Diseases


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