Coronary Artery Disease Clinical Trial
— COMBINEOfficial title:
Combined Optical Coherence Tomography Morphologic and Fractional Flow Reserve Hemodynamic Assessment of Non-Culprit Lesions to Better Predict Adverse Event Outcomes in Diabetes Mellitus Patients. COMBINE (OCT-FFR) Prospective Register
NCT number | NCT02989740 |
Other study ID # | 9241 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 26, 2015 |
Est. completion date | February 28, 2021 |
Verified date | August 2021 |
Source | Diagram B.V. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Title: Combined Optical Coherence Tomography Morphologic and Fractional Flow Reserve Hemodynamic Assessment of Non-Culprit Lesions to Better Predict Adverse Event Outcomes in Diabetes Mellitus Patients COMBINE (OCT-FFR) Prospective Register To study the natural evolution of patients with at least one intermediate angiographic but non-hemodynamic significant stenotic lesion, in two subgroups of patients, with TCFA vs. no TCFA as detected by OCT imaging and to compare these two groups of patients with each other as well as to a subset of patients with FFR-positive and PCI-treated intermediate lesions on future MACE.
Status | Completed |
Enrollment | 550 |
Est. completion date | February 28, 2021 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age = 18 years 2. History of DM with any indication for angiography (Stable Angina (SA) or any type of Acute Coronary Syndrome (ACS) including ST-Elevation MI). 3. Coronary angiography, including FFR and OCT imaging of at least one coronary de novo stenosis in a native not-grafted vessel with a visually estimated diameter stenosis (DS) of = 40 - = 80% (target lesion) . Target lesion should be other than the culprit lesion(s) in patients presenting with MI (STEMI or non-STEMI). Exclusion Criteria: 1. TIMI flow < 3 in the target lesion(s) 2. Target lesion reference diameter (on visual estimation) < 2.0 mm 3. Known left ventricular ejection fraction <30% 4. Known malignancy 5. Life expectancy < 2 years 6. Unwilling or unable to provide inform consent |
Country | Name | City | State |
---|---|---|---|
Netherlands | Isala | Zwolle | Overijssel |
Lead Sponsor | Collaborator |
---|---|
Diagram B.V. | Isala, St. Jude Medical Nederland B.V. |
Netherlands,
Kedhi E, Berta B, Roleder T, Hermanides RS, Fabris E, IJsselmuiden AJJ, Kauer F, Alfonso F, von Birgelen C, Escaned J, Camaro C, Kennedy MW, Pereira B, Magro M, Nef H, Reith S, Al Nooryani A, Rivero F, Malinowski K, De Luca G, Garcia Garcia H, Granada JF, — View Citation
Kennedy MW, Fabris E, Ijsselmuiden AJ, Nef H, Reith S, Escaned J, Alfonso F, van Royen N, Wojakowski W, Witkowski A, Indolfi C, Ottervanger JP, Suryapranata H, Kedhi E. Combined optical coherence tomography morphologic and fractional flow reserve hemodynamic assessment of non- culprit lesions to better predict adverse event outcomes in diabetes mellitus patients: COMBINE (OCT-FFR) prospective study. Rationale and design. Cardiovasc Diabetol. 2016 Oct 10;15(1):144. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The per patient incidence of the target lesion(s) related composite MACE | The per patient incidence of the target lesion(s) related composite MACE defined as Cardiac Death, MI, clinically-driven target lesion revascularisation or hospitalization due to unstable or progressive angina at 18 months in the FFR-negative No-TCFA (Group A) and FFR-negative TCFA (Group B). | 18 months after procedure | |
Secondary | The per patient incidence of the target lesion(s) related composite MACE: | Cardicac death, MI, clinically- driven revascularization or hospitalization due to unstable or progressive angina between FFR-negative TCFA (Group B) and the group of patients with PCI-treated FFR-positive lesions (Group C). | 18 months after procedure | |
Secondary | The per patient incidence composite MACE | The per patient incidence composite MACE: Cardiac death, MI, any clinically driven-revascularization or hospitalization due to unstable or progressive angina between FFR-negative TCFA (Group B) and the group of patients with PCI treated FFR positive lesions (Group C). | 18 months after procedure | |
Secondary | The incidence of MACE (Cardiac death, MI, any clinically driven-revascularization or hospitalization due to unstable or progressive angina) | deriving from non PCI treated lesions between TCFA hosting patients anywhere in the major coronary of stentable size vs. patients with no TCFA (this analysis will be run in the total pool of patients after treatment of all FFR positive lesions and does not take in account the angiographic severity of the lesions ie. the location of the TCFA can be elsewhere than the target lesion ) | 18 months after procedure |
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