NCT02224235

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 25, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

October 6, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

August 19, 2014

Last Update Submit

September 29, 2020

Conditions

Stable Angina

Keywords

Stable anginaPCIPercutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (18)

  • Neointimal coverage of the stent as measured using OCT

    Neointimal coverage of the stent as measured using OCT

    1 month

  • Neointimal coverage of the stent as measured using OCT

    Neointimal coverage of the stent as measured using OCT

    3 months

  • Presence of thrombus formation as measured by OCT

    Presence of thrombus formation as measured by OCT

    1 month

  • Presence of thrombus formation as measured by OCT

    Presence of thrombus formation as measured by OCT

    3 months

  • Proportion of uncovered struts as measured by OCT

    Proportion of uncovered struts as measured by OCT

    1 month

  • Proportion of uncovered struts as measured by OCT

    Proportion of uncovered struts as measured by OCT

    3 months

  • Presence of Malopposed struts as measured by OCT

    Presence of Malopposed struts as measured by OCT

    1 month

  • Presence of Malopposed struts as measured by OCT

    Presence of Malopposed struts as measured by OCT

    3 months

  • In-stent neointimal thickness measured using OCT

    In-stent neointimal thickness measured using OCT

    1 month

  • In-stent neointimal thickness measured by OCT

    In-stent neointimal thickness measured by OCT

    3 months

  • Lumen area measured by OCT

    Lumen area measured by OCT

    1 month

  • Lumen area measured by OCT

    Lumen area measured by OCT

    3 months

  • Lumen Volume measured by OCT

    Lumen Volume measured by OCT

    1 month

  • Lumen Volume measured by OCT

    Lumen Volume measured by OCT

    3 months

  • Stent area measured by OCT

    Stent area measured by OCT

    1 month

  • Stent area measured by OCT

    Stent area measured by OCT

    3 months

  • Stent volume measured by OCT

    Stent volume measured by OCT

    1 month

  • Stent volume measured by OCT

    Stent volume measured by OCT

    3 months

Other Outcomes (47)

  • In-stent late loss measured by angiography

    1 month

  • In-stent late loss measured by angiography

    3 months

  • In-segment late loss measured by angiography

    1 month

  • +44 more other outcomes

Study Arms (3)

Group 1- COBRA 1 week DAPT

EXPERIMENTAL

COBRA PzF coronary stent followed by dual anti-platelet therapy (DAPT) for one week

Device: COBRA PzFDrug: DAPT

Group 2 - DES 6 month DAPT

ACTIVE COMPARATOR

Resolute Integrity DES followed by dual anti-platelet therapy (DAPT) for at least 6 months

Device: Resolute Integrity DESDrug: DAPT

Group 3 - COBRA Aspirin

EXPERIMENTAL

COBRA PzF coronary stent followed by aspirin alone

Drug: AspirinDevice: COBRA PzF

Interventions

AspirinDRUG

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

Also known as: Ascriptin Enteric, Aspir 81, Aspir-Low, Bufferin, Easprin, Ecotrin, Ecpirin, Fasprin, Halfprin, Miniprin
Group 3 - COBRA Aspirin
Resolute Integrity DESDEVICE

Resolute Integrity DES

Group 2 - DES 6 month DAPT
COBRA PzFDEVICE
Also known as: COBRA PzF coronary stent system
Group 1- COBRA 1 week DAPTGroup 3 - COBRA Aspirin
DAPTDRUG

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

Also known as: Dual Anti Platelet Therapy
Group 1- COBRA 1 week DAPTGroup 2 - DES 6 month DAPT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Satakunta Central Hospital

Pori, 28500, Finland

Location

Heart Center, Turku University Hospital

Turku, 20520, Finland

Location

MeSH Terms

Conditions

Angina, Stable

Interventions

AspirinDual Anti-Platelet Therapy

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDrug Therapy, CombinationDrug TherapyTherapeutics

Study Officials

  • Pasi Karjalainen, MD, PhD

    Satakunta Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2014

First Posted

August 25, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

October 6, 2020

Record last verified: 2020-09

Locations

FI(2)