N/A
N=86
Wall Shear Stress and Neointimal Healing Following PCI in Angulated Coronary Vessels
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT02098876 ↗Enrolled (actual)
86
Serious AEs
4.7%
Results posted
Sep 2022
Primary outcome: Primary: In Stent Mean Cross-sectional Area of Neo-intimal Tissue Coverage — 1.381; 0.949 mm^2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Resolute Integrity Zotarolimus eluting stent (Device); Xience Xpedition everolimus eluting stent (Device); Optical Coherence Tomography (OCT) (Device); Intravascular Ultrasound (IVUS) (Device)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY In Stent Mean Cross-sectional Area of Neo-intimal Tissue Coverage |
1.381; 0.949 | — |
| SECONDARY In Stent: Mean Thickness of Strut Coverage at Follow up |
0.118; 0.096 | — |
| SECONDARY In-Stent: Degree of Vascular Straightening Post-percutaneous Coronary Intervention (PCI) (In-Stent Mechanistic Endpoint) |
40; 36 | — |
| SECONDARY In Stent: Plaque Prolapse Post-PCI (In-Stent Mechanistic Endpoint) |
0.12; 0.13 | — |
| SECONDARY In-Stent: Percent Area of Low Wall Shear Stress (WSS)-(In-Stent Mechanistic Endpoint) |
0.9; 0.9 | — |
| SECONDARY Stent Edge -Change in Plaque Area (Efficacy Endpoint) at 5 mm Proximal and Distal to Stent. |
-0.8; -0.5 | — |
| SECONDARY Stent Edge: Degree of Vascular Straightening Post-percutaneous Coronary Intervention (PCI) at the Stent Edges (Stent Edge Mechanistic Endpoint) |
22; 21 | — |
| SECONDARY Stent Edge: Percent Area With Low Wall Shear Stress (WSS) at Stent Edges Post-PCI (Mechanistic Endpoint) |
0.6; 0.64 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02098876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.