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COBRA SHIELD OCT Study

NCT02224235 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-10-06

No results posted yet for this study

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.

Conditions

  • Stable Angina

Interventions

DRUG

Aspirin

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

DEVICE

Resolute Integrity DES

Resolute Integrity DES

DEVICE

COBRA PzF

DRUG

DAPT

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

Sponsors & Collaborators

  • ClinLogix. LLC

    collaborator INDUSTRY

  • CeloNova BioSciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Pasi Karjalainen, MD, PhD · Satakunta Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Finland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02224235 on ClinicalTrials.gov