Graft Patency After FFR-guided Versus Angio-guided CABG (GRAFFITI) Trial
This study is currently recruiting participants.
(see Contacts and Locations)
Verified March 2013 by Onze Lieve Vrouw Hospital
Sponsor:
Onze Lieve Vrouw Hospital
Information provided by (Responsible Party):
Emanuele Barbato, Onze Lieve Vrouw Hospital
ClinicalTrials.gov Identifier:
NCT01810224
First received: March 9, 2013
Last updated: March 11, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Procedure: Surgical revascularization |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Graft Patency After FFR-guided Versus Angio-guided CABG: a Prospective, Multicenter, Multinational, Randomized (1:1) Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Onze Lieve Vrouw Hospital:
Primary Outcome Measures:
- Rate of occluded bypass grafts [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 206 |
| Study Start Date: | March 2013 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Angio-guided arm
In this arm will be included the patient randomized to a Angiography-guided surgical revascularization strategy.
|
Procedure: Surgical revascularization
The final intervention (surgical revascularization) will be the same for both arms.
|
|
Experimental: FFR-guided arm
In this arm will be included the patient randomized to a FFR-guided surgical revascularization strategy.
|
Procedure: Surgical revascularization
The final intervention (surgical revascularization) will be the same for both arms.
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with stable angina, unstable angina or NSTEMI candidate to CABG
- Significant LAD and/or LM lesion - proved by FFR or Angiography AND
- At least one more, angiographycally intermediate lesion
Exclusion Criteria:
- Significant valvular disease with indication to surgical replacement
- Severe left ventricular dysfunction (EF<35%)
- Acute STEMI
- Atrial fibrillation, if Maze procedure is planned
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01810224
Please refer to this study by its ClinicalTrials.gov identifier: NCT01810224
Contacts
| Contact: Emanuele Barbato, MD, PhD | emanuele.barbato@olvz-aalst.be |
Locations
| Belgium | |
| Cardiovascular Center Aalst OLV Hospital | Recruiting |
| Aalst, Belgium, 9300 | |
| Principal Investigator: Emanuele Barbato, MD, PhD | |
| Principal Investigator: Bernard De Bruyne, MD, PhD | |
| Principal Investigator: Gabor Toth, MD | |
| Czech Republic | |
| Department of Internal Medicine and Cardiology, University Hospital Brno | Not yet recruiting |
| Brno, Czech Republic | |
| Contact: Petr Kala, MD kalapetr7@gmail.com | |
| Principal Investigator: Petr Kala, MD | |
| Hungary | |
| Hungarian Institute of Cardiology | Not yet recruiting |
| Budapest, Hungary | |
| Contact: Zsolt Piroth piroth@freemail.hu | |
| Principal Investigator: Zsolt Piroth, MD, PhD | |
Sponsors and Collaborators
Onze Lieve Vrouw Hospital
Investigators
| Principal Investigator: | Emanuele Barbato, MD, PhD | Cardiovascular Center Aalst, OLV Hospital, Aalst (Belgium) |
More Information
No publications provided
| Responsible Party: | Emanuele Barbato, Doctor, Onze Lieve Vrouw Hospital |
| ClinicalTrials.gov Identifier: | NCT01810224 History of Changes |
| Other Study ID Numbers: | GRAFFITI |
| Study First Received: | March 9, 2013 |
| Last Updated: | March 11, 2013 |
| Health Authority: | Belgium: Ethics Committee |
Additional relevant MeSH terms:
|
Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases |
Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases |
ClinicalTrials.gov processed this record on March 03, 2015