Phase one of this study is a prospective, randomized (2:1), pilot study that will evaluate COBRA PzF vascular healing patterns and thrombus formation with Optical Coherence Tomography (OCT) at 3 months after stent implantation in comparison with Resolute Integrity drug eluting stent (DES). Patients in the COBRA PzF (Group 1) will receive dual anti platelets for one week followed by aspirin, while patients implanted with ZES (Group 2), will receive Dual anti-platelet therapy (DAPT) for at least 6 months followed by aspirin. After the completion of Phase 1, Phase 2 will enroll 10 patients in the COBRA PzF (Group 3). Patients in Group 3 will receive aspirin alone and have OCT at one month after the stent procedure to evaluate COBRA PzF vascular healing patterns and thrombus formation at one month follow up.
Phase one of this study is a prospective, randomized (2:1), pilot study that will evaluate COBRA PzF vascular healing patterns and thrombus formation with Optical Coherence Tomography (OCT) at 3 months after stent implantation in comparison with Resolute Integrity drug eluting stent (DES). Patients in the COBRA PzF (Group 1) will receive dual anti platelets for one week followed by aspirin, while patients implanted with ZES (Group 2), will receive Dual anti-platelet therapy (DAPT) for at least 6 months followed by aspirin. After the completion of Phase 1, Phase 2 will enroll 10 patients in the COBRA PzF (Group 3). Patients in Group 3 will receive aspirin alone and have OCT at one month after the stent procedure to evaluate COBRA PzF vascular healing patterns and thrombus formation at one month follow up. This study was terminated after enrollment of 8 patients due to insufficient enrollment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
75-325 mg q.d. aspirin until study completion (recommended indefinitely for stent patients)
Resolute Integrity DES
At the discretion of the investigator as to which DAPT is administered (per local practice)
Satakunta Central Hospital
Pori, Finland
Heart Center, Turku University Hospital
Turku, Finland
Neointimal coverage of the stent as measured using OCT
Neointimal coverage of the stent as measured using OCT
Time frame: 1 month
Neointimal coverage of the stent as measured using OCT
Neointimal coverage of the stent as measured using OCT
Time frame: 3 months
Presence of thrombus formation as measured by OCT
Presence of thrombus formation as measured by OCT
Time frame: 1 month
Presence of thrombus formation as measured by OCT
Presence of thrombus formation as measured by OCT
Time frame: 3 months
Proportion of uncovered struts as measured by OCT
Proportion of uncovered struts as measured by OCT
Time frame: 1 month
Proportion of uncovered struts as measured by OCT
Proportion of uncovered struts as measured by OCT
Time frame: 3 months
Presence of Malopposed struts as measured by OCT
Presence of Malopposed struts as measured by OCT
Time frame: 1 month
Presence of Malopposed struts as measured by OCT
Presence of Malopposed struts as measured by OCT
Time frame: 3 months
In-stent neointimal thickness measured using OCT
In-stent neointimal thickness measured using OCT
Time frame: 1 month
In-stent neointimal thickness measured by OCT
In-stent neointimal thickness measured by OCT
Time frame: 3 months
Lumen area measured by OCT
Lumen area measured by OCT
Time frame: 1 month
Lumen area measured by OCT
Lumen area measured by OCT
Time frame: 3 months
Lumen Volume measured by OCT
Lumen Volume measured by OCT
Time frame: 1 month
Lumen Volume measured by OCT
Lumen Volume measured by OCT
Time frame: 3 months
Stent area measured by OCT
Stent area measured by OCT
Time frame: 1 month
Stent area measured by OCT
Stent area measured by OCT
Time frame: 3 months
Stent volume measured by OCT
Stent volume measured by OCT
Time frame: 1 month
Stent volume measured by OCT
Stent volume measured by OCT
Time frame: 3 months
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