Clinical trial NCT02224235: COBRA SHIELD OCT Study
Official title: COBRA PZF™ Coronary Stent System in Native Coronary Arteries for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-term Dual Anti-platelet Therapy: OCT (Optical Coherence Tomography) Evaluation in Comparison With DES
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stable Angina
Keywords: Stable angina
PCI
Percutaneous Coronary Intervention
Lead sponsor: CeloNova BioSciences, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ClinLogix. LLC
First posted: 2014-08-25
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Neointimal coverage of the stent as measured using OCT
timeFrame: 1 month
measure: Neointimal coverage of the stent as measured using OCT
timeFrame: 3 months
measure: Presence of thrombus formation as measured by OCT
timeFrame: 1 month
measure: Presence of thrombus formation as measured by OCT
timeFrame: 3 months
measure: Proportion of uncovered struts as measured by OCT
timeFrame: 1 month
measure: Proportion of uncovered struts as measured by OCT
timeFrame: 3 months
measure: Presence of Malopposed struts as measured by OCT
timeFrame: 1 month
measure: Presence of Malopposed struts as measured by OCT
timeFrame: 3 months
measure: In-stent neointimal thickness measured using OCT
timeFrame: 1 month
measure: In-stent neointimal thickness measured by OCT
timeFrame: 3 months
measure: Lumen area measured by OCT
timeFrame: 1 month
measure: Lumen area measured by OCT
timeFrame: 3 months
measure: Lumen Volume measured by OCT
timeFrame: 1 month
measure: Lumen Volume measured by OCT
timeFrame: 3 months
measure: Stent area measured by OCT
timeFrame: 1 month
measure: Stent area measured by OCT
timeFrame: 3 months
measure: Stent volume measured by OCT
timeFrame: 1 month
measure: Stent volume measured by OCT
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
measure: In-stent late loss measured by angiography
timeFrame: 1 month
measure: In-stent late loss measured by angiography
timeFrame: 3 months
measure: In-segment late loss measured by angiography
timeFrame: 1 month
measure: In-segment late loss measured by angiography
timeFrame: 3 months
measure: In-stent percent diameter stenosis measured by angiography
timeFrame: 1 month
measure: In-stent percent diameter stenosis measured by angiography
timeFrame: 3 months
measure: In-segment percent diameter stenosis measured by angiography
timeFrame: 1 month
measure: In-segment percent diameter stenosis measured by angiography
timeFrame: 3 months
measure: In-stent binary stenosis measured by angiography
timeFrame: 1 month
measure: In-stent binary stenosis measured by angiography
timeFrame: 3 months
measure: In-segment binary stenosis measured by angiography
timeFrame: 1 month
measure: In-segment binary stenosis measured by angiography
timeFrame: 3 months
measure: In-stent minimum lumen diameter measured by angiography
timeFrame: 1 month
measure: n-stent minimum lumen diameter measured by angiography
timeFrame: 3 months
measure: In-segment minimum lumen diameter (MLD) measured by angiography
timeFrame: 1 month
measure: In-segment minimum lumen diameter (MLD) measured by angiography
timeFrame: 3 months
measure: Longitudinal stent deformation measured by angiography
timeFrame: 1 month
measure: Longitudinal stent deformation measured by angiography
timeFrame: 3 months
measure: Presence of stent fracture measured by angiography
timeFrame: 1 month
measure: Presence of stent fracture measured by angiography
timeFrame: 3 months
measure: All Deaths
timeFrame: 1 month
measure: All Deaths
timeFrame: 6 months
measure: All Deaths
timeFrame: 12 months
measure: Cardiac Death
timeFrame: 1 month
measure: Cardiac Death
timeFrame: 6 months
measure: Cardiac Death
timeFrame: 12 months
measure: Major Adverse Cardiac Events
timeFrame: 1 month
measure: Major Adverse Cardiac Events
timeFrame: 6 months
measure: Major Adverse Cardiac Events
timeFrame: 12 months
measure: Myocardial Infarction
timeFrame: 1 month
measure: Myocardial Infarction
timeFrame: 6 months
measure: Myocardial Infarction
timeFrame: 12 months
measure: Composite endpoint of cardiac death and MI
timeFrame: 1 month
measure: Composite endpoint of cardiac death and MI
timeFrame: 6 months
measure: Composite endpoint of cardiac death and MI
timeFrame: 12 months
measure: Clinically driven Target Lesion Revascularization
timeFrame: 1 month
measure: Clinically driven Target Lesion Revascularization
timeFrame: 6 months
measure: Clinically driven Target Lesion Revascularization
timeFrame: 12 months
measure: Clinically driven target vessel revascularization
timeFrame: 1 month
measure: Clinically driven target vessel revascularization
timeFrame: 6 months
measure: Clinically driven target vessel revascularization
timeFrame: 12 months
measure: Occurrence of Stroke post index procedure
timeFrame: 1 month
measure: Occurrence of Stroke post index procedure
timeFrame: 6 months
measure: Occurrence of Stroke post index procedure
timeFrame: 12 months
measure: Acute success
timeFrame: 30 days
measure: Bleeding or vascular complications
timeFrame: At time of hospital discharge (expected average to be within 2 days of index procedure
measure: Stent Thrombosis
timeFrame: 3 months
Locations:
city: Pori
country: Finland
facility: Satakunta Central Hospital
city: Turku
country: Finland
facility: Heart Center, Turku University Hospital
Study officials:
affiliation: Satakunta Central Hospital
name: Pasi Karjalainen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: