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Stable AnginaNCT02224235

COBRA SHIELD OCT Study

A study testing Aspirin, Resolute Integrity DES and COBRA PzF in people with Stable Angina, run by CeloNova BioSciences, Inc. at 2 sites in Finland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stable Angina
What is being tested?
Aspirin, Resolute Integrity DES and COBRA PzF
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
2 sitesFinland
Study dates
Jun 2014to Jun 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

2 sites in 1 country.

Finland2 sites

  • Satakunta Central Hospital

    Pori, 28500

  • Heart Center, Turku University Hospital

    Turku, 20520

Other trials in Finland

About this 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

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.

Read the 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

Conditions
Stable Angina
Being tested
Aspirin, Resolute Integrity DES, COBRA PzF, DAPT
Keywords
Stable angina, PCI, Percutaneous Coronary Intervention
Medical subject headings
Angina, Stable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AspirinDrug

    Also called Ascriptin Enteric, Aspir 81, Aspir-Low, Bufferin

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

  • Resolute Integrity DESDevice

    Resolute Integrity DES

  • COBRA PzFDevice

    Also called COBRA PzF coronary stent system

  • DAPTDrug

    Also called Dual Anti Platelet Therapy

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

Study groups in NCT02224235
Study groupRoleWhat they receive
Group 1- COBRA 1 week DAPTExperimentalCOBRA PzF coronary stent followed by dual anti-platelet therapy (DAPT) for one week
Receives: Device: COBRA PzF; Drug: DAPT
Group 2 - DES 6 month DAPTActive comparatorResolute Integrity DES followed by dual anti-platelet therapy (DAPT) for at least 6 months
Receives: Device: Resolute Integrity DES; Drug: DAPT
Group 3 - COBRA AspirinExperimentalCOBRA PzF coronary stent followed by aspirin alone
Receives: Drug: Aspirin; Device: COBRA PzF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neointimal coverage of the stent as measured using OCT

    Neointimal coverage of the stent as measured using OCT

    Measured: 1 month

  2. Neointimal coverage of the stent as measured using OCT

    Neointimal coverage of the stent as measured using OCT

    Measured: 3 months

  3. Presence of thrombus formation as measured by OCT

    Presence of thrombus formation as measured by OCT

    Measured: 1 month

  4. Presence of thrombus formation as measured by OCT

    Presence of thrombus formation as measured by OCT

    Measured: 3 months

  5. Proportion of uncovered struts as measured by OCT

    Proportion of uncovered struts as measured by OCT

    Measured: 1 month

  6. Proportion of uncovered struts as measured by OCT

    Proportion of uncovered struts as measured by OCT

    Measured: 3 months

  7. Presence of Malopposed struts as measured by OCT

    Presence of Malopposed struts as measured by OCT

    Measured: 1 month

  8. Presence of Malopposed struts as measured by OCT

    Presence of Malopposed struts as measured by OCT

    Measured: 3 months

  9. In-stent neointimal thickness measured using OCT

    In-stent neointimal thickness measured using OCT

    Measured: 1 month

  10. In-stent neointimal thickness measured by OCT

    In-stent neointimal thickness measured by OCT

    Measured: 3 months

  11. Lumen area measured by OCT

    Lumen area measured by OCT

    Measured: 1 month

  12. Lumen area measured by OCT

    Lumen area measured by OCT

    Measured: 3 months

  13. Lumen Volume measured by OCT

    Lumen Volume measured by OCT

    Measured: 1 month

  14. Lumen Volume measured by OCT

    Lumen Volume measured by OCT

    Measured: 3 months

  15. Stent area measured by OCT

    Stent area measured by OCT

    Measured: 1 month

  16. Stent area measured by OCT

    Stent area measured by OCT

    Measured: 3 months

  17. Stent volume measured by OCT

    Stent volume measured by OCT

    Measured: 1 month

  18. Stent volume measured by OCT

    Stent volume measured by OCT

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

Why it stopped: Inadequate enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02224235
Sponsor's protocol ID
COBRA 2013-02
Status last verified
Sep 2020
First submitted
19 Aug 2014
Last updated
6 Oct 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Aspirin, Resolute Integrity DES and COBRA PzF in people with Stable Angina, run by CeloNova BioSciences, Inc. at 2 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Inadequate enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neointimal coverage of the stent as measured using OCT (time frame: 1 month). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02224235.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.

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