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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01170988
Other study ID # FLUSS001AHK
Secondary ID
Status Completed
Phase N/A
First received July 27, 2010
Last updated August 5, 2014
Start date August 2010
Est. completion date August 2014

Study information

Verified date August 2014
Source Johann Wolfgang Goethe University Hospitals
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

Is the surgical treatment of patients with coronary heart disease using the T-graft technique an adequate solution that provides a sufficient myocardial flow reserve? A magnetic resonance examination (MRI) is required.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- coronary heart disease

- Age > 18 ys

- Ejection fraction > 45%

Exclusion Criteria:

- myocardial infarction

- Re-Intervention

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
T-Graft
T-Graft

Locations

Country Name City State
Germany Johann Wolfgang Goethe Universitätsklinikum Frankfurt am Main

Sponsors (2)

Lead Sponsor Collaborator
Johann Wolfgang Goethe University Hospitals Bethanien Krankenhaus gGmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Coronary flow reserve within 4-6 weeks Yes
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