Stable Angina
Conditions
Keywords
Stable angina, PCI, Percutaneous Coronary Intervention
Brief summary
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.
Detailed description
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
Interventions
Sponsors
ClinLogix. LLC
CeloNova BioSciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient \>= 18 years old. * Eligible for percutaneous coronary intervention (PCI). * Patient provides written informed consent. * Patient is willing to comply with follow-up evaluation. * Acceptable candidate for coronary artery bypass graft (CABG) surgery. * Stable angina pectoris or a positive functional ischemia study. * Male or non-pregnant female patient * Patient indicated for elective stenting of up to 2 stenotic lesions in two separate native coronary arteries. * Reference vessel \>=2.5 mm and\<= 4.0 mm in diameter by visual estimate. * Target lesion \<=20 mm in length by visual estimate. * Protected left main lesion with \>50% stenosis. * Target lesion stenosis \>= 70% and \< 100% by visual estimate OR Target lesion stenosis \<70% who meet physiological criteria for revascularization (i.e. positive Fractional Flow Reserve).
Exclusion criteria
* Currently enrolled in another investigational device or drug trial. * Previously enrolled in another stent trial within the prior 2 years. * ANY planned elective surgery or percutaneous intervention within the subsequent 3 months. * A previous coronary interventional procedure of any kind within 30 days prior to the procedure. * The patient requires staged procedure of either the target or any non-target vessel before OCT procedure at 3 months post-procedure. * The target lesion requires treatment with a device other than percutaneous transluminal coronary angioplasty (PTCA) prior to stent placement. * Previous drug eluting stent (DES) or bare metal stent (BMS) deployment anywhere in the target vessel. * Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial. * Concurrent medical condition with a life expectancy of less than 12 months. * Documented left ventricular ejection fraction (LVEF) \< 50% at the most recent evaluation. * Patients with diagnosis of myocardial infarction (MI) within 72 hours (i.e. CK-MB must be returned to normal prior to enrollment) or suspected acute MI at time of enrollment. * Previous intervention in the target vessel. * History of cerebrovascular accident or transient ischemic attack in the last 6 months. * Leukopenia (leukocytes \< 3.5 x10\^9 / liter). * Neutropenia (Absolute Neutrophil Count \< 1000/mm3) \<= 3 days prior to enrollment. * Thrombocytopenia (platelets \< 100,000/mm3) pre-procedure. * Active peptic ulcer or active GI bleeding. * History of bleeding diathesis or coagulopathy or inability to accept blood transfusions. * Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, L-605 Cobalt chromium alloy or sensitivity to contrast media, which cannot be adequately pre-medicated. * Serum creatinine level \> 2.0 mg/dl within 7 days prior to index procedure. * Patients not responsive to Plavix/ aspirin and or unable to tolerate Plavix/ aspirin for 6 month post procedure. * Patient on or may require anticoagulation therapy within 3 months of index procedure. * Flow limiting dissections observed on OCT * Significant tissue prolapse within the stent observed on OCT * Unprotected left main coronary artery disease * Target vessel with any lesions with greater than 60% diameter stenosis outside of a range of 5 mm proximal and distal to the target lesion based on visual estimate or on-line quantitative coronary arteriography (QCA). * Target lesion (or vessel) exhibiting an intraluminal thrombus (occupying \> 50% of the true lumen diameter) at any time. * Lesion location that is aorto-ostial or within 5 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX). * Target lesion with side branches \> 2.0mm in diameter. * Target vessel is excessively tortuous (two bends \> 90˚ to reach the target lesion). * Target lesion is severely calcified. * Thrombolysis In Myocardial Infarction (TIMI) flow 0 or 1 * Target lesion is in a bypass graft
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neointimal coverage of the stent as measured using OCT | 1 month | Neointimal coverage of the stent as measured using OCT |
| Presence of thrombus formation as measured by OCT | 1 month | Presence of thrombus formation as measured by OCT |
| Proportion of uncovered struts as measured by OCT | 1 month | Proportion of uncovered struts as measured by OCT |
| Presence of Malopposed struts as measured by OCT | 1 month | Presence of Malopposed struts as measured by OCT |
| In-stent neointimal thickness measured using OCT | 1 month | In-stent neointimal thickness measured using OCT |
| In-stent neointimal thickness measured by OCT | 3 months | In-stent neointimal thickness measured by OCT |
| Lumen area measured by OCT | 1 month | Lumen area measured by OCT |
| Lumen Volume measured by OCT | 1 month | Lumen Volume measured by OCT |
| Stent area measured by OCT | 1 month | Stent area measured by OCT |
| Stent volume measured by OCT | 1 month | Stent volume measured by OCT |
Other
| Measure | Time frame | Description |
|---|---|---|
| Presence of stent fracture measured by angiography | 1 month | Presence of stent fracture measured by angiography |
| All Deaths | 1 month | All Deaths from any cause post index procedure |
| Cardiac Death | 1 month | Death due to cardiac cause post index procedure |
| Major Adverse Cardiac Events | 1 month | 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 |
| Myocardial Infarction | 1 month | Occurrence of myocardial infarction. Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQWMI). |
| Composite endpoint of cardiac death and MI | 1 month | Composite endpoint of Cardiac Death and MI |
| In-stent late loss measured by angiography | 1 month | In-stent late loss measured by angiography |
| Clinically driven target vessel revascularization | 1 month | 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. |
| Occurrence of Stroke post index procedure | 1 month | Stroke (ischemic and hemorrhagic) |
| Acute success | 30 days | 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. |
| Bleeding or vascular complications | At time of hospital discharge (expected average to be within 2 days of index procedure | 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. |
| Stent Thrombosis | 3 months | 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. |
| Clinically driven Target Lesion Revascularization | 1 month | 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. |
| In-segment late loss measured by angiography | 1 month | In-segment late loss measured by angiography |
| In-stent percent diameter stenosis measured by angiography | 1 month | In-stent percent diameter stenosis (%DS) measured by angiography |
| In-segment percent diameter stenosis measured by angiography | 1 month | In-segment percent diameter stenosis measured by angiography (%DS) (within the 5 mm margins proximal and distal to stent) |
| In-stent binary stenosis measured by angiography | 1 month | In-stent binary stenosis measured by angiography |
| In-segment binary stenosis measured by angiography | 1 month | In-segment binary stenosis measured by angiography (stenosis of \> 50% of the reference vessel diameter) |
| In-stent minimum lumen diameter measured by angiography | 1 month | In-stent minimum lumen diameter (MLD) measured by angiography |
| n-stent minimum lumen diameter measured by angiography | 3 months | In-stent minimum lumen diameter (MLD) measured by angiography |
| In-segment minimum lumen diameter (MLD) measured by angiography | 1 month | In-segment MLD measured by angiography |
| Longitudinal stent deformation measured by angiography | 1 month | Longitudinal stent deformation measured by angiography |
Countries
Finland
Outcome results
None listed