Clinical trial NCT02919943: Observational Study of Angiographic Coregistered Optical Coherence Tomography in Patients Undergoing PCI
Official title: Impact of Angiographic Coregistered Optical Coherence Tomography-diagnostics on Physicians Decision-making During Percutaneous Coronary Intervention in Patients With Advanced Coronary Artery Disease - the "OPTICO-Integration-Trial"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2016-09-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elective or ad hoc PCI, stable Angina, acute coronary syndrome

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


Eligibility criteria: 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

Primary outcomes:
measure: The primary study objective is the change in PCI strategy after pre-procedural ACR as compared to OCT imaging alone
timeFrame: 20 months
Secondary outcomes:
measure: Major adverse cardiac event (MACE)-rate (death, myocardial infarction, Re-angiography, Re-PCI and renal failure requiring dialysis), after recruitment.
timeFrame: 30 days, 6 months, and 12 months.
measure: Change in PCI strategy after pre-procedural OCT imaging in comparison to conventional angiography alone.
timeFrame: 20 months
measure: Longitudinal geographical miss (GM) with uncovered residual parts of "target lesion" at the proximal or distal reference segment of the stent. Detected by comparison between pre-PCI OCT with post-PCI OCT.
timeFrame: 20 months
measure: Rate of side branch occlusions (%).
timeFrame: 20 months
measure: Strategy changes based on post-procedural OCT and ACR Imaging.
timeFrame: 20 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: David M Leistner, PD
role: PRINCIPAL_INVESTIGATOR
References: