Graft Patency After FFR-guided Versus Angio-guided CABG (GRAFFITI) Trial (GRAFFITI)
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ClinicalTrials.gov Identifier: NCT01810224 |
Recruitment Status
: Unknown
Verified March 2013 by Emanuele Barbato, Onze Lieve Vrouw Hospital.
Recruitment status was: Recruiting
First Posted
: March 13, 2013
Last Update Posted
: March 13, 2013
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Sponsor:
Onze Lieve Vrouw Hospital
Information provided by (Responsible Party):
Emanuele Barbato, Onze Lieve Vrouw Hospital
Tracking Information | ||||
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First Submitted Date ICMJE | March 9, 2013 | |||
First Posted Date ICMJE | March 13, 2013 | |||
Last Update Posted Date | March 13, 2013 | |||
Study Start Date ICMJE | March 2013 | |||
Estimated Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Rate of occluded bypass grafts [ Time Frame: 1 year ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
a) Lenght of hospital stay; b) Changes in surgical strategy: i.e. open-chest surgery vs. mini-thoracotomy; extensive surgery versus minimal invasive approaches. [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3-4 weeks ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Graft Patency After FFR-guided Versus Angio-guided CABG (GRAFFITI) Trial | |||
Official Title ICMJE | Graft Patency After FFR-guided Versus Angio-guided CABG: a Prospective, Multicenter, Multinational, Randomized (1:1) Controlled Trial | |||
Brief Summary | This is prospective, randomized, multicenter, multinational, randomized (1:1) study. The aim of this study is to assess the importance of functional assessment of coronary artery disease prior to bypass surgery. In particular, an FFR-guided strategy will be compared to the traditional Angio-guided strategy in the guidance of surgical revascularization by aorto-coronary bypass grafting. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Coronary Artery Disease | |||
Intervention ICMJE | Procedure: Surgical revascularization
The final intervention (surgical revascularization) will be the same for both arms. |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
206 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Study Completion Date | Not Provided | |||
Estimated Primary Completion Date | December 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 90 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Czech Republic, Hungary | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01810224 | |||
Other Study ID Numbers ICMJE | GRAFFITI | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Emanuele Barbato, Onze Lieve Vrouw Hospital | |||
Study Sponsor ICMJE | Onze Lieve Vrouw Hospital | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Onze Lieve Vrouw Hospital | |||
Verification Date | March 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |