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Coil Embolization of Coronary Artery Fistulas

Primary Purpose

C14, C14907933, C14907933125

Status
Completed
Phase
Locations
Spain
Study Type
Observational
Intervention
Coil
Sponsored by
HOSPITEN
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for C14 focused on measuring coronary fistulas., coils embolization.

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Coronary artery fistulas Clinical diagnosis of angina, myocardial infarction, left ventricular insufficiency, ventricular enlargement Exclusion Criteria: Age <18 or > 85 years Cardiogenic shock _ severe ventricular enlargement

Sites / Locations

  • HOSPITEN

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
October 16, 2008
Sponsor
HOSPITEN
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1. Study Identification

Unique Protocol Identification Number
NCT00198016
Brief Title
Coil Embolization of Coronary Artery Fistulas
Official Title
Coil Embolization of Coronary Artery Fistulas: A Single Centre Experience
Study Type
Observational

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
HOSPITEN

4. Oversight

5. Study Description

Brief Summary
Background and Purpose: Congenital coronary artery fistula (CAF) is an uncommon anomaly. In some patients they can became symptomatic, associated with significant morbidity and mortality. We report our experience in percutaneous treatment of CAF.
Detailed Description
Congenital coronary artery fistula (CAF) can be defined as a direct communication of a coronary artery with a cardiac chamber, great vessel, or other vascular structure, bypassing the myocardial capillary bed. CAF is an uncommon anomaly, occurring as an incidental finding in 0.1% to 0.2% of coronary angiograms. They are not gender specific. Many patients have symptoms like congestive heart failure, infective endocarditis, myocardial ischemia, or rupture of an aneurismal fistula. Surgical closure of coronary artery fistula was initially reported in 1983 with low rates of morbidity and mortality. Percutaneous treatment appeared as an alternative to surgery. Transcatheter closure of CAF was first utilized in 1983. Along this years, with experience and improvements in catheterization equipment and occlusion devices, CAF occlusion have been successfully performed using microcoils. We report our experience in using microcoils to percutaneous treatment of coronary fistulas.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
C14, C14907933, C14907933125, G09330582163324, C14280647250
Keywords
coronary fistulas., coils embolization.

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Coil

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Coronary artery fistulas Clinical diagnosis of angina, myocardial infarction, left ventricular insufficiency, ventricular enlargement Exclusion Criteria: Age <18 or > 85 years Cardiogenic shock _ severe ventricular enlargement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zuheir Kabbani, Cardiology
Organizational Affiliation
HOSPITEN
Official's Role
Study Director
Facility Information:
Facility Name
HOSPITEN
City
Santa Cruz
State/Province
Tenerife
ZIP/Postal Code
38001
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Coil Embolization of Coronary Artery Fistulas

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