N/A
N=450
OPTIMIZE PCI: Multicenter Randomized Trial of OCT Compared to IVUS and Angiography to Guide Coronary Stent Implantation
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT02471586 ↗Enrolled (actual)
450
Serious AEs
19.6%
Results posted
Apr 2021
Primary outcome: Primary: Primary Efficacy Endpoint (Powered): Post-PCI Median Minimum Stent Area (MSA) — 5.79; 5.89; 5.49 mm^2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Coronary PCI guided by IVUS (Procedure); Coronary PCI guided by OCT (Procedure); Coronary PCI guided by Angiography (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Efficacy Endpoint (Powered): Post-PCI Median Minimum Stent Area (MSA) |
5.79; 5.89; 5.49 | — |
| PRIMARY Primary Safety Endpoint (Non-powered): Number of Participants With Procedural MACE (Major Adverse Cardiac Event) |
4; 1; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Acute Procedural Success |
36; 32; 23; 22; 16; 5 | — |
| SECONDARY Rate of Post-PCI Stent Expansion (%) |
87.6; 86.5; 82.9 | — |
| SECONDARY Rate of Mean Stent Expansion (%) |
105.8; 106.3; 101.4 | — |
| SECONDARY Number of Participants With Plaque Protrusion and Thrombus |
27; 27; 25; 67; 73; 70 | — |
| SECONDARY Number of Participants With Untreated Reference Segment Disease |
44; 45; 39 | — |
| SECONDARY Number of Participants With Edge Dissections |
19; 35; 26; 20; 18; 35 | — |
| SECONDARY Number of Participants With Stent Malapposition |
15; 28; 44; 43; 24; 39 | — |
| SECONDARY Number of Participants With Border Detection (OCT Arm Only) |
7; 0; 0; 28; 0; 0 | — |
| SECONDARY Number of Participants With Altered Clinical Decision Making on the Basis of the Post-stent Imaging Run |
53; 78; 0; 97; 62; 0 | — |
| SECONDARY Median Intra-stent Lumen Area (Intra-stent Flow Area) |
5.54; 5.71; 5.42 | — |
| SECONDARY Median Effective Lumen Area (Total Flow Area) |
5.68; 5.87; 5.52 | — |
| SECONDARY IVUS Secondary Endpoints: Comparison of Number of Participants With Dissection IVUS vs. OCT Imaging (IVUS Arm Only) |
35; 15; 0; 18; 7; 0 | — |
| SECONDARY IVUS Secondary Endpoints: Comparison of Number of Participants With Malapposition IVUS vs. OCT Imaging (IVUS Arm Only) |
28; 20; 0; 24; 7; 0 | — |
| SECONDARY IVUS Secondary Endpoints: Comparison of Number of Participants With Plaque or Thrombus Protrusion IVUS vs. OCT Imaging (IVUS Arm Only) |
27; 10; 0; 73; 17; 0 | — |
| SECONDARY Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter |
2.71; 2.78; 2.71; 2.30; 2.41; 2.37 | — |
| SECONDARY Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Minimal Lumen Diameter |
2.71; 2.78; 2.71; 2.30; 2.41; 2.37 | — |
| SECONDARY Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis |
5.0; 5.1; 6.2; 14.7; 13.4; 13.0 | — |
| SECONDARY Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Diameter Stenosis |
5.0; 5.1; 6.2; 14.7; 13.4; 13.0 | — |
| SECONDARY Non OCT Secondary Endpoints (Angiographic Endpoints (QCA)) - Median Acute Lumen Gain Post-intervention |
1.76; 1.75; 1.75; 1.32; 1.38; 1.36 | — |
| SECONDARY Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio |
2.82; 2.84; 2.72 | — |
| SECONDARY Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Median Maximum Stent Size/Reference Vessel Diameter Ratio |
2.82; 2.84; 2.72 | — |
| SECONDARY Non OCT Secondary Endpoints - Angiographic Endpoints (QCA): Number of Participants With Angiographic Dissection ≥ NHLBI Type B |
1; 1; 1 | — |
| SECONDARY Procedural Endpoints (Site Reported): Median Total Stent Length |
23.5; 24.0; 20.0 | — |
| SECONDARY Procedural Endpoints (Site Reported): Median Stents Per Lesion |
1; 1; 1 | — |
| SECONDARY Procedural Endpoints (Site Reported) - Median Maximal Stent Size |
3.00; 3.00; 3.00 | — |
| SECONDARY Procedural Endpoints (Site Reported) - Median Post-dilatation Inflations |
2; 2; 1 | — |
| SECONDARY Procedural Endpoints (Site Reported): Median Maximum Inflation Pressure (Atm.) |
18; 20; 18 | — |
| SECONDARY Procedural Endpoints (Site Reported): Number of Participants With Additional Interventions |
51; 28; 0; 57; 40; 0 | — |
| SECONDARY Additional Procedural and Clinical Endpoints: Number of Participants With Angiography Defined Procedural Success Rate |
135; 130; 131 | — |
| SECONDARY Additional Procedural and Clinical Endpoints - Number of Participants With Device Success Rate |
149; 139; 0 | — |
| SECONDARY Additional Procedural and Clinical Endpoints - Number of Participants With Target Lesion Failure (TLF) |
4; 6; 2 | — |
| SECONDARY Additional Procedural and Clinical Endpoints - Number of Participants With Peri-procedural Myocardial Infarction |
1; 1; 0 | — |
Summary
The objective of this clinical investigation is to demonstrate the safety and efficacy of an OCT guided strategy for stent implantation
Eligibility Criteria
General Inclusion Criteria:
- Age ≥ 18 years.
- Patient with an indication for PCI including:
- Angina (stable or unstable),
- Silent ischemia (a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present),
- NSTEMI, or
- Recent STEMI (>24 hours from initial presentation and stable).
- Patients will undergo cardiac catheterization and possible or definite PCI with intent to stent using any non-investigational metallic drug-eluting stent (DES)
- Signed written informed consent
Angiographic inclusion criteria:
- The target lesion must be located in a native coronary artery with visually estimated reference vessel diameter of ≥2.25 mm to ≤3.50 mm.
- Lesion length 1/3 of lungs) or radiographic interstitial or alveolar pulmonary edema
- Subject is intubated.
- Known LVEF 50%, or any additional target vessel stenosis which requires PCI either during or within 12 months after the study procedure
- Left main diameter stenosis ≥30% or left main PCI planned.
- Study target lesion in a bypass graft
- Ostial RCA study target lesion
- Chronic total occlusion (TIMI flow 0/1) study target lesion
- Bifurcation study lesion with a planned dual stent strategy
- In-stent restenosis study target lesion
- Any study lesion characteristic resulting in the expected inability to deliver the IVUS or OCT catheter to the lesion pre and post PCI (e.g. moderate or severe vessel calcification or tortuosity)
Data sourced from ClinicalTrials.gov (NCT02471586). 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.