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

Coronary Artery Disease Clinical Trial

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02919943
• Other study ID #: OPTICO-Integration I
• Status: Completed
• Phase: N/A
• First received: September 27, 2016
• Last updated: May 14, 2017
• Start date: July 2016
• Est. completion date: September 2016

Study information

• Verified date: May 2017
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Percutaneous Coronary Intervention
OCT-guided Percutaneous Coronary Intervention.

Locations

Country	Name	City	State
Germany	Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary study objective is the change in PCI strategy after pre-procedural ACR as compared to OCT imaging alone		20 months
Secondary	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.
Secondary	Change in PCI strategy after pre-procedural OCT imaging in comparison to conventional angiography alone.		20 months
Secondary	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
Secondary	Rate of side branch occlusions (%).		20 months
Secondary	Strategy changes based on post-procedural OCT and ACR Imaging.		20 months