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

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"

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Percutaneous Coronary Intervention

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Elective or ad hoc PCI, stable Angina, acute coronary syndrome

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary study objective is the change in PCI strategy after pre-procedural ACR as compared to OCT imaging alone	20 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Major adverse cardiac event (MACE)-rate (death, myocardial infarction, Re-angiography, Re-PCI and renal failure requiring dialysis), after recruitment.	30 days, 6 months, and 12 months.
Change in PCI strategy after pre-procedural OCT imaging in comparison to conventional angiography alone.	20 months
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.	20 months
Rate of side branch occlusions (%).	20 months
Strategy changes based on post-procedural OCT and ACR Imaging.	20 months

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: David M Leistner, PD, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: September 27, 2016
• First Submitted That Met QC Criteria: September 28, 2016
• First Posted (Estimate): September 30, 2016

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 14, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: OPTICO-Integration I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED