Observational Study of Angiographic Coregistered Optical Coherence Tomography in Patients Undergoing PCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-09-30

Brief Summary

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To define and evaluate the impact of angiographic coregistered OCT on physicians decision-making through prospective data collection in PCI procedures.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Percutaneous Coronary Intervention

OCT-guided Percutaneous Coronary Intervention.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years.
* Patient provides signed written informed consent before any study-specific procedure.
* Patients suffer from coronary artery disease (CAD) including at least one angiographically significant (\>70% visual estimation) stenosis present in a native coronary artery with planned PCI.

Exclusion Criteria

* Subjects with emergent PCI or in cardiogenic shock.
* Subjects with target left main (LM) lesion, with restenosis or stent thrombosis in the target vessel or with aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
* Extreme angulation (\> 90°) or excessive tortuosity (\> two 45° angles) proximal to or within the target lesion.
* Known renal insufficiency (examples being but not limited to estimated glomerular Filtration rate (eGFR) \< 50 ml/kg/m2, serum creatinine ≥ 2.5 mg/dL or on dialysis).
* Any other medical condition that in the opinion of the investigator will interfere with patients safety or study results.
* Currently participating in another clinical study that interferes with study results.
* Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.
* Any condition that precludes the subject from undergoing PCI, for example subjects with heparin induced thrombocytopenia, or contrast allergy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No