Calcium Reduction by Orbital Atherectomy in Western Europe

Launched by ERASMUS MEDICAL CENTER · Sep 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called orbital atherectomy, which is used to treat severely calcified blockages in the coronary arteries. These blockages can make it difficult for doctors to place a stent, a small tube that helps keep the artery open. The goal of the study is to see if using orbital atherectomy improves the expansion of the stent and to understand how the procedure prepares the blocked area for treatment. Participants in the trial will receive orbital atherectomy guided by advanced imaging technology to help doctors see inside the arteries clearly, followed by stent placement.

To be eligible for this trial, participants must be adults between the ages of 65 and 74 with a specific type of coronary artery blockage that is severely calcified. This means that the blockage shows clear signs of hardening and must meet certain imaging criteria. Some people may not qualify if they have certain conditions, like significant heart problems or prior treatments on the affected artery. For those who do participate, they can expect to undergo the orbital atherectomy procedure and receive close monitoring throughout the study to assess how well the treatment works.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • De novo significant native coronary artery lesion
• • The target lesion must have evidence of severe calcification: 1) presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall with calcification length of at least 15 mm and extend partially into the target lesion. 2) OR presence of ≥ 270° of calcium or lumen protruding calcified nodules at \>1 cross section by intravascular imaging (OCT)
• • The target vessel reference diameter ≥ 2.5 mm and ≤ 4.0 mm and lesion must not exceed 40 mm in length
• Exclusion Criteria:
• • Left main disease
• • Prior stenting of the target vessel
• • Target lesion has thrombus or dissection
• • Known left ventricular ejection fraction LVEF ≤ 25%
• • Diagnosed with chronic renal failure (GFR \< 30 ml/min)
• • Confirmed pregnancy
• • Life expectancy \< 12 months
• • Coronary anatomy that prevents delivery of OCT catheter
• • Known allergy to soybean oil, egg yolk phospholipids, glycerin or sodium hydroxide