Feasibility of Orbital Atherectomy System in Calcified Bifurcation Lesion

Completed

Conditions studied: Coronary Artery Disease

In brief

ORBID-OA is a single-center, observational study in 30 patients with stable coronary artery disease. The aim of the study is to analyze the outcomes of main vessel stenting on side branch in calcified bifurcation lesion and identify preprocedural predictors of side branch complication by utilizing two-dimensional (2D) and three-dimensional (3D) frequency domain optical coherence tomography (FD-OCT).

Key facts

Study ID

NCT03058510

Run by

Icahn School of Medicine at Mount Sinai

People needed

30

Starts

2016-01-17

Expected to finish

2017-10-13

Last updated by the study team

2017-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients over 18 years of age presenting with stable coronary artery disease.
• Angiographic lesion with severe calcification with or without side branch (SB) in whom provisional main vessel stenting strategy is planned after reviewing angiogram will be recruited

You may not qualify if…

• Patients with ostial left main artery lesions or ostial right coronary artery lesions
• Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding
• Known allergy to acetylsalicylic acid or clopidogrel.
• Planned surgery within 12 months.
• History of bleeding diathesis
• Major surgery within 15 days
• Life expectancy < 12 months.
• Patients with kidney dysfunction (CrCl<30)

Where it is running

• Icahn School of Medicine at Mount Sinai and the Mount Sinai Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.