Wall Shear Stress and Neointimal Healing Following PCI in Angulated Coronary Vessels

Completed · Not applicable

Conditions studied: Coronary Artery Disease

In brief

Stents are metallic tubular supports placed inside a blood vessel to relieve an obstruction and restore blood flow to the heart muscle. Stents could also be coated with a drug (drug-eluting stents - DES) that improves local healing and inhibits growth of scar tissue within the vessel that otherwise could lead to re-narrowing. This study will evaluate the effects of 2 FDA-approved metallic stents with different designs that may have important effects on regional plaque response and blood flow dynamics immediately after stent deployment and stent healing at 12 months follow up.

Key facts

Study ID

NCT02098876

Run by

Emory University

People needed

86

Starts

2014-05-01

Expected to finish

2020-12-01

Last updated by the study team

2022-09-09

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must be 30 to 80 years old
• Severe coronary lesion in a vessel with ≥ 30-degree angulation requiring percutaneous coronary intervention (PCI)
• Lesion treatable by a single Resolute Integrity or Onyx Abbott Xience Xpedition or Sierra coronary drug-eluting stent.
• Patients with stable ischemic heart disease or acute coronary syndrome undergoing clinically PCI.

You may not qualify if…

• Inability to provide informed consent prior to randomization
• Anatomy requiring coronary artery bypass surgery (CABG)
• History of prior CABG in the territory of the vessel being considered for PCI
• Heavily calcified lesion requiring rotablation or other debulking or scoring device for successful stent deployment
• Large thrombus burden on recent angiography
• Previously stented vessels
• Ostial lesions: lesion located within 5mm of the origin of the left anterior descending artery (LAD), left circumflex artery (LCx), or Right coronary artery (RCA)
• Lesions at bifurcations and those that occlude side branches >2.5mm
• Recent (<72 hours) ST-elevation myocardial infarction (STEMI).
• Planned surgical procedures in the subsequent 12 months
• History of hypersensitivity or contraindication to device materials and their degradants, everolimus, zotarolimus, cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoropolymers
• History of any solid organ transplantation or subject is on a waiting list for any solid organ transplant
• Left ventricular ejection fraction < 30%
• Known allergies to clinically utilized anti-thrombotic or anti-platelet agents
• Unable to tolerate long term dual antiplatelet therapy
• Pregnancy or lactation

Where it is running

• Emory University — Atlanta, Georgia, United States
• Nanjing Medical University, Nanjing Heart Center — Nanjing, China
• Kobe University Graduate School of Medicine — Hyōgo, Japan
• Wakayama Medical University Department of Cardiovascular Medicine — Wakayama, Japan
• Latvian Society of Cardiology Pauls Stradins Clinical University Hospital — Riga, Latvia
• University Clinical Center of Serbia — Belgrade, Serbia
• Seoul National University College of Medicine — Seoul, South Korea
• Samsung Medical Center, Sungkyunkwan University School of Medicine Division of Cardiology — Seoul, South Korea
• Ulsan University Hospital University of Ulsan College of Medicine — Ulsan, South Korea
• Hospital Clinico San Carlos, Universidad Complutense de Madrid — Madrid, Spain

Full record on ClinicalTrials.gov

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