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Clinical Study Protocol - Debris Interventional Removal in ACS (DESIRE-ACS)

NCT02325869 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-07-28

No results posted yet for this study

Summary

DebriS Interventional REmoval in ACS (DESIRE-ACS) Study to assess the safety and performance of the ECA Bell balloon in subjects undergoing coronary percutaneous interventions.

Conditions

  • Coronary Disease
  • Acute Coronary Syndrome
  • Coronary Occlusion

Interventions

DEVICE

Bell Balloon Catheter

An angioplasty procedure to open the blockage in blood vessels will be performed. Standard angioplasty procedure includes local analgesia of the groin area and a small cut through which the procedure will be performed. An introducer sheath (thin tube) will be inserted. The Bell Balloon dilatation will then be inserted. The Bell Balloon works in fashion similar to standard balloon with the same physical and behavioral characteristics. Upon deflation, debris from the blockage is withdrawn into the cavity formed between the deflated balloon and its outer capsule. Then balloon is retracted and retrieved through the guiding catheter, together with the captured debris and trap it between the outer surface of the balloon and the inner surface of the membrane.

Sponsors & Collaborators

  • Angioslide Ltd.

    lead INDUSTRY

Principal Investigators

  • Giora Weisz, Prof. M.D · Chairman, Department of Cardiology. Shaare Zedek Medical Center, Jerusalem Israel

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2015-12-31
Completion
2016-03-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02325869 on ClinicalTrials.gov