COBRA SHIELD OCT Study

September 29, 2020 updated by: CeloNova BioSciences, Inc.

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

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.

Study Overview

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

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Pori, Finland, 28500
        • Satakunta Central Hospital
      • Turku, Finland, 20520
        • Heart Center, Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1- COBRA 1 week DAPT
COBRA PzF coronary stent followed by dual anti-platelet therapy (DAPT) for one week
Other Names:
  • COBRA PzF coronary stent system
At the discretion of the investigator as to which DAPT is administered (per local practice)
Other Names:
  • Dual Anti Platelet Therapy
Active Comparator: Group 2 - DES 6 month DAPT
Resolute Integrity DES followed by dual anti-platelet therapy (DAPT) for at least 6 months
At the discretion of the investigator as to which DAPT is administered (per local practice)
Other Names:
  • Dual Anti Platelet Therapy
Resolute Integrity DES
Experimental: Group 3 - COBRA Aspirin
COBRA PzF coronary stent followed by aspirin alone
Other Names:
  • COBRA PzF coronary stent system
75-325 mg q.d. aspirin until study completion (recommended indefinitely for stent patients)
Other Names:
  • Ecotrin
  • Bufferin
  • Ascriptin Enteric
  • Aspir-Low
  • Easprin
  • Ecpirin
  • Fasprin
  • Halfprin
  • Miniprin
  • Aspir 81

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neointimal coverage of the stent as measured using OCT
Time Frame: 1 month
Neointimal coverage of the stent as measured using OCT
1 month
Neointimal coverage of the stent as measured using OCT
Time Frame: 3 months
Neointimal coverage of the stent as measured using OCT
3 months
Presence of thrombus formation as measured by OCT
Time Frame: 1 month
Presence of thrombus formation as measured by OCT
1 month
Presence of thrombus formation as measured by OCT
Time Frame: 3 months
Presence of thrombus formation as measured by OCT
3 months
Proportion of uncovered struts as measured by OCT
Time Frame: 1 month
Proportion of uncovered struts as measured by OCT
1 month
Proportion of uncovered struts as measured by OCT
Time Frame: 3 months
Proportion of uncovered struts as measured by OCT
3 months
Presence of Malopposed struts as measured by OCT
Time Frame: 1 month
Presence of Malopposed struts as measured by OCT
1 month
Presence of Malopposed struts as measured by OCT
Time Frame: 3 months
Presence of Malopposed struts as measured by OCT
3 months
In-stent neointimal thickness measured using OCT
Time Frame: 1 month
In-stent neointimal thickness measured using OCT
1 month
In-stent neointimal thickness measured by OCT
Time Frame: 3 months
In-stent neointimal thickness measured by OCT
3 months
Lumen area measured by OCT
Time Frame: 1 month
Lumen area measured by OCT
1 month
Lumen area measured by OCT
Time Frame: 3 months
Lumen area measured by OCT
3 months
Lumen Volume measured by OCT
Time Frame: 1 month
Lumen Volume measured by OCT
1 month
Lumen Volume measured by OCT
Time Frame: 3 months
Lumen Volume measured by OCT
3 months
Stent area measured by OCT
Time Frame: 1 month
Stent area measured by OCT
1 month
Stent area measured by OCT
Time Frame: 3 months
Stent area measured by OCT
3 months
Stent volume measured by OCT
Time Frame: 1 month
Stent volume measured by OCT
1 month
Stent volume measured by OCT
Time Frame: 3 months
Stent volume measured by OCT
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-stent late loss measured by angiography
Time Frame: 1 month
In-stent late loss measured by angiography
1 month
In-stent late loss measured by angiography
Time Frame: 3 months
In-stent late loss measured by angiography
3 months
In-segment late loss measured by angiography
Time Frame: 1 month
In-segment late loss measured by angiography
1 month
In-segment late loss measured by angiography
Time Frame: 3 months
In-segment late loss measured by angiography
3 months
In-stent percent diameter stenosis measured by angiography
Time Frame: 1 month
In-stent percent diameter stenosis (%DS) measured by angiography
1 month
In-stent percent diameter stenosis measured by angiography
Time Frame: 3 months
In-stent percent diameter stenosis (%DS) measured by angiography
3 months
In-segment percent diameter stenosis measured by angiography
Time Frame: 1 month
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
Time Frame: 3 months
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
Time Frame: 1 month
In-stent binary stenosis measured by angiography
1 month
In-stent binary stenosis measured by angiography
Time Frame: 3 months
In-stent binary stenosis measured by angiography(stenosis of > 50% of the reference vessel diameter)
3 months
In-segment binary stenosis measured by angiography
Time Frame: 1 month
In-segment binary stenosis measured by angiography (stenosis of > 50% of the reference vessel diameter)
1 month
In-segment binary stenosis measured by angiography
Time Frame: 3 months
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
Time Frame: 1 month
In-stent minimum lumen diameter (MLD) measured by angiography
1 month
n-stent minimum lumen diameter measured by angiography
Time Frame: 3 months
In-stent minimum lumen diameter (MLD) measured by angiography
3 months
In-segment minimum lumen diameter (MLD) measured by angiography
Time Frame: 1 month
In-segment MLD measured by angiography
1 month
In-segment minimum lumen diameter (MLD) measured by angiography
Time Frame: 3 months
In-segment MLD measured by angiography
3 months
Longitudinal stent deformation measured by angiography
Time Frame: 1 month
Longitudinal stent deformation measured by angiography
1 month
Longitudinal stent deformation measured by angiography
Time Frame: 3 months
Longitudinal stent deformation measured by angiography
3 months
Presence of stent fracture measured by angiography
Time Frame: 1 month
Presence of stent fracture measured by angiography
1 month
Presence of stent fracture measured by angiography
Time Frame: 3 months
Presence of stent fracture measured by angiography
3 months
All Deaths
Time Frame: 1 month
All Deaths from any cause post index procedure
1 month
All Deaths
Time Frame: 6 months
All Deaths from any cause post index procedure
6 months
All Deaths
Time Frame: 12 months
All Deaths from any cause post index procedure
12 months
Cardiac Death
Time Frame: 1 month
Death due to cardiac cause post index procedure
1 month
Cardiac Death
Time Frame: 6 months
Death due to cardiac cause post index procedure
6 months
Cardiac Death
Time Frame: 12 months
Death due to cardiac cause post index procedure
12 months
Major Adverse Cardiac Events
Time Frame: 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
1 month
Major Adverse Cardiac Events
Time Frame: 6 months
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
Time Frame: 12 months
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
Time Frame: 1 month
Occurrence of myocardial infarction. Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQWMI).
1 month
Myocardial Infarction
Time Frame: 6 months
Occurrence of myocardial infarction. Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQWMI).
6 months
Myocardial Infarction
Time Frame: 12 months
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
Time Frame: 1 month
Composite endpoint of Cardiac Death and MI
1 month
Composite endpoint of cardiac death and MI
Time Frame: 6 months
Composite endpoint of Cardiac Death and MI
6 months
Composite endpoint of cardiac death and MI
Time Frame: 12 months
Composite endpoint of Cardiac Death and MI
12 months
Clinically driven Target Lesion Revascularization
Time Frame: 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.
1 month
Clinically driven Target Lesion Revascularization
Time Frame: 6 months
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
Time Frame: 12 months
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
Time Frame: 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.
1 month
Clinically driven target vessel revascularization
Time Frame: 6 months
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
Time Frame: 12 months
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
Time Frame: 1 month
Stroke (ischemic and hemorrhagic)
1 month
Occurrence of Stroke post index procedure
Time Frame: 6 months
Stroke (ischemic and hemorrhagic)
6 months
Occurrence of Stroke post index procedure
Time Frame: 12 months
Stroke (ischemic and hemorrhagic)
12 months
Acute success
Time Frame: 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.

30 days
Bleeding or vascular complications
Time Frame: 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.

At time of hospital discharge (expected average to be within 2 days of index procedure
Stent Thrombosis
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Pasi Karjalainen, MD, PhD, Satakunta Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 19, 2014

First Submitted That Met QC Criteria

August 21, 2014

First Posted (Estimate)

August 25, 2014

Study Record Updates

Last Update Posted (Actual)

October 6, 2020

Last Update Submitted That Met QC Criteria

September 29, 2020

Last Verified

September 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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