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Inadequate enrollment
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| Name | Class |
|---|---|
| ClinLogix. LLC | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1- COBRA 1 week DAPT | Experimental | COBRA PzF coronary stent followed by dual anti-platelet therapy (DAPT) for one week |
|
| Group 2 - DES 6 month DAPT | Active Comparator | Resolute Integrity DES followed by dual anti-platelet therapy (DAPT) for at least 6 months |
|
| Group 3 - COBRA Aspirin | Experimental | COBRA PzF coronary stent followed by aspirin alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | 75-325 mg q.d. aspirin until study completion (recommended indefinitely for stent patients) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neointimal coverage of the stent as measured using OCT | Neointimal coverage of the stent as measured using OCT | 1 month |
| Neointimal coverage of the stent as measured using OCT | Neointimal coverage of the stent as measured using OCT | 3 months |
| Presence of thrombus formation as measured by OCT | Presence of thrombus formation as measured by OCT | 1 month |
| Presence of thrombus formation as measured by OCT | Presence of thrombus formation as measured by OCT | 3 months |
| Proportion of uncovered struts as measured by OCT | Proportion of uncovered struts as measured by OCT | 1 month |
| Proportion of uncovered struts as measured by OCT | Proportion of uncovered struts as measured by OCT | 3 months |
| Presence of Malopposed struts as measured by OCT | Presence of Malopposed struts as measured by OCT | 1 month |
| Presence of Malopposed struts as measured by OCT | Presence of Malopposed struts as measured by OCT |
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| Measure | Description | Time Frame |
|---|---|---|
| In-stent late loss measured by angiography | In-stent late loss measured by angiography | 1 month |
| In-stent late loss measured by angiography | In-stent late loss measured by angiography |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pasi Karjalainen, MD, PhD | Satakunta Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Satakunta Central Hospital | Pori | 28500 | Finland | |||
| Heart Center, Turku University Hospital |
| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000080903 | Dual Anti-Platelet Therapy |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Resolute Integrity DES | Device | Resolute Integrity DES |
|
| COBRA PzF | Device |
|
|
| DAPT | Drug | At the discretion of the investigator as to which DAPT is administered (per local practice) |
|
|
| 3 months |
| In-stent neointimal thickness measured using OCT | In-stent neointimal thickness measured using OCT | 1 month |
| In-stent neointimal thickness measured by OCT | In-stent neointimal thickness measured by OCT | 3 months |
| Lumen area measured by OCT | Lumen area measured by OCT | 1 month |
| Lumen area measured by OCT | Lumen area measured by OCT | 3 months |
| Lumen Volume measured by OCT | Lumen Volume measured by OCT | 1 month |
| Lumen Volume measured by OCT | Lumen Volume measured by OCT | 3 months |
| Stent area measured by OCT | Stent area measured by OCT | 1 month |
| Stent area measured by OCT | Stent area measured by OCT | 3 months |
| Stent volume measured by OCT | Stent volume measured by OCT | 1 month |
| Stent volume measured by OCT | Stent volume measured by OCT | 3 months |
| 3 months |
| In-segment late loss measured by angiography | In-segment late loss measured by angiography | 1 month |
| In-segment late loss measured by angiography | In-segment late loss measured by angiography | 3 months |
| In-stent percent diameter stenosis measured by angiography | In-stent percent diameter stenosis (%DS) measured by angiography | 1 month |
| In-stent percent diameter stenosis measured by angiography | In-stent percent diameter stenosis (%DS) measured by angiography | 3 months |
| In-segment percent diameter stenosis measured by angiography | In-segment percent diameter stenosis measured by angiography (%DS) (within the 5 mm margins proximal and distal to stent) | 1 month |
| In-segment percent diameter stenosis measured by angiography | In-segment percent diameter stenosis measured by angiography (%DS) (within the 5 mm margins proximal and distal to stent) | 3 months |
| In-stent binary stenosis measured by angiography | In-stent binary stenosis measured by angiography | 1 month |
| In-stent binary stenosis measured by angiography | In-stent binary stenosis measured by angiography(stenosis of > 50% of the reference vessel diameter) | 3 months |
| In-segment binary stenosis measured by angiography | In-segment binary stenosis measured by angiography (stenosis of > 50% of the reference vessel diameter) | 1 month |
| In-segment binary stenosis measured by angiography | In-segment binary stenosis measured by angiography (stenosis of > 50% of the reference vessel diameter) | 3 months |
| In-stent minimum lumen diameter measured by angiography | In-stent minimum lumen diameter (MLD) measured by angiography | 1 month |
| n-stent minimum lumen diameter measured by angiography | In-stent minimum lumen diameter (MLD) measured by angiography | 3 months |
| In-segment minimum lumen diameter (MLD) measured by angiography | In-segment MLD measured by angiography | 1 month |
| In-segment minimum lumen diameter (MLD) measured by angiography | In-segment MLD measured by angiography | 3 months |
| Longitudinal stent deformation measured by angiography | Longitudinal stent deformation measured by angiography | 1 month |
| Longitudinal stent deformation measured by angiography | Longitudinal stent deformation measured by angiography | 3 months |
| Presence of stent fracture measured by angiography | Presence of stent fracture measured by angiography | 1 month |
| Presence of stent fracture measured by angiography | Presence of stent fracture measured by angiography | 3 months |
| All Deaths | All Deaths from any cause post index procedure | 1 month |
| All Deaths | All Deaths from any cause post index procedure | 6 months |
| All Deaths | All Deaths from any cause post index procedure | 12 months |
| Cardiac Death | Death due to cardiac cause post index procedure | 1 month |
| Cardiac Death | Death due to cardiac cause post index procedure | 6 months |
| Cardiac Death | Death due to cardiac cause post index procedure | 12 months |
| Major Adverse Cardiac Events | Major Adverse Cardiac Events (MACE) defined as cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods | 1 month |
| Major Adverse Cardiac Events | Major Adverse Cardiac Events (MACE) defined as cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods | 6 months |
| Major Adverse Cardiac Events | Major Adverse Cardiac Events (MACE) defined as cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods | 12 months |
| Myocardial Infarction | Occurrence of myocardial infarction. Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQWMI). | 1 month |
| Myocardial Infarction | Occurrence of myocardial infarction. Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQWMI). | 6 months |
| Myocardial Infarction | Occurrence of myocardial infarction. Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQWMI). | 12 months |
| Composite endpoint of cardiac death and MI | Composite endpoint of Cardiac Death and MI | 1 month |
| Composite endpoint of cardiac death and MI | Composite endpoint of Cardiac Death and MI | 6 months |
| Composite endpoint of cardiac death and MI | Composite endpoint of Cardiac Death and MI | 12 months |
| Clinically driven Target Lesion Revascularization | Clinically driven TLR. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent. | 1 month |
| Clinically driven Target Lesion Revascularization | Clinically driven TLR. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent. | 6 months |
| Clinically driven Target Lesion Revascularization | Clinically driven TLR. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent. | 12 months |
| Clinically driven target vessel revascularization | Clinically driven TVR. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. | 1 month |
| Clinically driven target vessel revascularization | Clinically driven TVR. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. | 6 months |
| Clinically driven target vessel revascularization | Clinically driven TVR. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. | 12 months |
| Occurrence of Stroke post index procedure | Stroke (ischemic and hemorrhagic) | 1 month |
| Occurrence of Stroke post index procedure | Stroke (ischemic and hemorrhagic) | 6 months |
| Occurrence of Stroke post index procedure | Stroke (ischemic and hemorrhagic) | 12 months |
| Acute success | Device Success: Defined as the attainment of < 30% final residual stenosis of the target lesion using only the COBRA PzFTM Coronary Stent System Lesion Success: Defined as the attainment of < 30% final residual stenosis of the target lesion using any percutaneous method. Procedure Success: Attainment of < 30% residual stenosis of the target lesion and no in-hospital MACE. | 30 days |
| Bleeding or vascular complications | Bleeding Complications: Defined as a procedure-related hemorrhagic event that requires a transfusion and/or surgical intervention. Vascular Complications may include pseudoaneurysm, arteriovenous fistula (AVF), peripheral ischemia/nerve injury, and vascular event requiring transfusion or surgical repair. | At time of hospital discharge (expected average to be within 2 days of index procedure |
| Stent Thrombosis | Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the patient has left the catheterization laboratory. | 3 months |
| Turku |
| 20520 |
| Finland |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004359 | Drug Therapy, Combination |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |