COBRA SHIELD OCT Study

Stable Angina Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02224235
• Other study ID #: COBRA 2013-02
• Status: Terminated
• Phase: N/A
• Start date: June 2014
• Est. completion date: June 2015

Study information

• Verified date: September 2020
• Source: CeloNova BioSciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina, Stable
• Stable Angina

Intervention

Drug:
• Aspirin
75-325 mg q.d. aspirin until study completion (recommended indefinitely for stent patients)

Device:
• Resolute Integrity DES
Resolute Integrity DES
• COBRA PzF

Drug:
• DAPT
At the discretion of the investigator as to which DAPT is administered (per local practice)

Locations

Country	Name	City	State
Finland	Satakunta Central Hospital	Pori
Finland	Heart Center, Turku University Hospital	Turku

Sponsors (2)

Lead Sponsor	Collaborator
CeloNova BioSciences, Inc.	ClinLogix. LLC

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	In-stent late loss measured by angiography	In-stent late loss measured by angiography	1 month
Other	In-stent late loss measured by angiography	In-stent late loss measured by angiography	3 months
Other	In-segment late loss measured by angiography	In-segment late loss measured by angiography	1 month
Other	In-segment late loss measured by angiography	In-segment late loss measured by angiography	3 months
Other	In-stent percent diameter stenosis measured by angiography	In-stent percent diameter stenosis (%DS) measured by angiography	1 month
Other	In-stent percent diameter stenosis measured by angiography	In-stent percent diameter stenosis (%DS) measured by angiography	3 months
Other	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
Other	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
Other	In-stent binary stenosis measured by angiography	In-stent binary stenosis measured by angiography	1 month
Other	In-stent binary stenosis measured by angiography	In-stent binary stenosis measured by angiography(stenosis of > 50% of the reference vessel diameter)	3 months
Other	In-segment binary stenosis measured by angiography	In-segment binary stenosis measured by angiography (stenosis of > 50% of the reference vessel diameter)	1 month
Other	In-segment binary stenosis measured by angiography	In-segment binary stenosis measured by angiography (stenosis of > 50% of the reference vessel diameter)	3 months
Other	In-stent minimum lumen diameter measured by angiography	In-stent minimum lumen diameter (MLD) measured by angiography	1 month
Other	n-stent minimum lumen diameter measured by angiography	In-stent minimum lumen diameter (MLD) measured by angiography	3 months
Other	In-segment minimum lumen diameter (MLD) measured by angiography	In-segment MLD measured by angiography	1 month
Other	In-segment minimum lumen diameter (MLD) measured by angiography	In-segment MLD measured by angiography	3 months
Other	Longitudinal stent deformation measured by angiography	Longitudinal stent deformation measured by angiography	1 month
Other	Longitudinal stent deformation measured by angiography	Longitudinal stent deformation measured by angiography	3 months
Other	Presence of stent fracture measured by angiography	Presence of stent fracture measured by angiography	1 month
Other	Presence of stent fracture measured by angiography	Presence of stent fracture measured by angiography	3 months
Other	All Deaths	All Deaths from any cause post index procedure	1 month
Other	All Deaths	All Deaths from any cause post index procedure	6 months
Other	All Deaths	All Deaths from any cause post index procedure	12 months
Other	Cardiac Death	Death due to cardiac cause post index procedure	1 month
Other	Cardiac Death	Death due to cardiac cause post index procedure	6 months
Other	Cardiac Death	Death due to cardiac cause post index procedure	12 months
Other	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
Other	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
Other	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
Other	Myocardial Infarction	Occurrence of myocardial infarction. Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQWMI).	1 month
Other	Myocardial Infarction	Occurrence of myocardial infarction. Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQWMI).	6 months
Other	Myocardial Infarction	Occurrence of myocardial infarction. Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQWMI).	12 months
Other	Composite endpoint of cardiac death and MI	Composite endpoint of Cardiac Death and MI	1 month
Other	Composite endpoint of cardiac death and MI	Composite endpoint of Cardiac Death and MI	6 months
Other	Composite endpoint of cardiac death and MI	Composite endpoint of Cardiac Death and MI	12 months
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Occurrence of Stroke post index procedure	Stroke (ischemic and hemorrhagic)	1 month
Other	Occurrence of Stroke post index procedure	Stroke (ischemic and hemorrhagic)	6 months
Other	Occurrence of Stroke post index procedure	Stroke (ischemic and hemorrhagic)	12 months
Other	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
Other	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
Other	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
Primary	Neointimal coverage of the stent as measured using OCT	Neointimal coverage of the stent as measured using OCT	1 month
Primary	Neointimal coverage of the stent as measured using OCT	Neointimal coverage of the stent as measured using OCT	3 months
Primary	Presence of thrombus formation as measured by OCT	Presence of thrombus formation as measured by OCT	1 month
Primary	Presence of thrombus formation as measured by OCT	Presence of thrombus formation as measured by OCT	3 months
Primary	Proportion of uncovered struts as measured by OCT	Proportion of uncovered struts as measured by OCT	1 month
Primary	Proportion of uncovered struts as measured by OCT	Proportion of uncovered struts as measured by OCT	3 months
Primary	Presence of Malopposed struts as measured by OCT	Presence of Malopposed struts as measured by OCT	1 month
Primary	Presence of Malopposed struts as measured by OCT	Presence of Malopposed struts as measured by OCT	3 months
Primary	In-stent neointimal thickness measured using OCT	In-stent neointimal thickness measured using OCT	1 month
Primary	In-stent neointimal thickness measured by OCT	In-stent neointimal thickness measured by OCT	3 months
Primary	Lumen area measured by OCT	Lumen area measured by OCT	1 month
Primary	Lumen area measured by OCT	Lumen area measured by OCT	3 months
Primary	Lumen Volume measured by OCT	Lumen Volume measured by OCT	1 month
Primary	Lumen Volume measured by OCT	Lumen Volume measured by OCT	3 months
Primary	Stent area measured by OCT	Stent area measured by OCT	1 month
Primary	Stent area measured by OCT	Stent area measured by OCT	3 months
Primary	Stent volume measured by OCT	Stent volume measured by OCT	1 month
Primary	Stent volume measured by OCT	Stent volume measured by OCT	3 months