OPTIMIZE PCI: Multicenter Randomized Trial of OCT Compared to IVUS and Angiography to Guide Coronary Stent Implantation

NCT ID: NCT02471586

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-04-25

Brief Summary

The objective of this clinical investigation is to demonstrate the safety and efficacy of an OCT guided strategy for stent implantation

Detailed Description

This is a prospective, post-market, international, multi-center, randomized clinical investigation in which the participants will be randomized in 1:1:1 ratio to undergo PCI with either OCT, IVUS, or Angiography guidance. The clinical investigation will be conducted at approximately 35 sites in the United States and outside the United States; approximately 25% of subjects will be enrolled in the United States.

Patients in the IVUS and OCT groups patients will undergo baseline and post PCI imaging with their randomized modality. In addition, the Angiography group and IVUS groups will undergo a blinded post-PCI OCT run to allow comparison of OCT derived minimum stent area (MSA) in both groups.

After hospital discharge, all patients will have clinical follow-up at 30 days, and 1 year.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Coronary PCI guided by IVUS

Intervention = Coronary stenting with planned drug eluting stent (DES).

Stenting will be performed with IVUS guidance according to local standard practice. IVUS imaging is required pre and post stent implantation.

At the end of the procedure, a final IVUS imaging run must be performed.

After the final IVUS run, a blinded OCT imaging run shall be performed to document final stent dimensions and results.

Group Type: ACTIVE_COMPARATOR

Coronary PCI guided by IVUS

Intervention Type: PROCEDURE

Imaging type

Coronary PCI guided by OCT

Intervention = Coronary stenting with planned drug eluting stent (DES).

Stenting will be performed with OCT guidance according to the algorithm described in the protocol. OCT imaging is required pre and post stent implantation.

At the end of the procedure, a final OCT imaging run must be performed.

Group Type: ACTIVE_COMPARATOR

Coronary PCI guided by OCT

Intervention Type: PROCEDURE

Imaging type

Coronary PCI guided by Angiography

Intervention = Coronary stenting with planned drug eluting stent (DES).

Stenting will be performed with angiography guidance according to local standard practice.

At the end of the procedure, a blinded OCT shall be performed to document final stent dimensions and results.

Group Type: ACTIVE_COMPARATOR

Coronary PCI guided by Angiography

Intervention Type: PROCEDURE

Imaging type

Interventions

Coronary PCI guided by IVUS

Imaging type

Intervention Type: PROCEDURE

Coronary PCI guided by OCT

Imaging type

Intervention Type: PROCEDURE

Coronary PCI guided by Angiography

Imaging type

Intervention Type: PROCEDURE

Other Intervention Names

Intravascular Ultrasound; Optical Coherence Tomography

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years.

2. 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).

3. Patients will undergo cardiac catheterization and possible or definite PCI with intent to stent using any non-investigational metallic drug-eluting stent (DES)

4. Signed written informed consent

1. 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.

2. Lesion length <40mm

Exclusion Criteria

1. Estimated creatinine clearance <30 ml/min using Cockcroft-Gault equation, unless the patient is on dialysis

2. STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital.

3. PCI within 24 hours preceding the study procedure.

4. PCI of a lesion within the target vessel within 12 months prior to the study procedure

5. Planned use of bare metal stent (BMS)

6. Planned use of bioresorbable vascular scaffold (BVS)

7. Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP, at time of procedure.

8. Mobitz II second degree or complete heart block

9. Malignant ventricular arrhythmias requiring treatment

10. Pulmonary edema defined as patient with shortness of breath, evidence of volume overload on physical exam, and crepitations on physical exam (>1/3 of lungs) or radiographic interstitial or alveolar pulmonary edema

11. Subject is intubated.

12. Known LVEF <30%.

13. Severe valvular disease (e.g. severe mitral regurgitation or severe aortic stenosis)

14. Cerebrovascular accident or transient ischemic attack within the past 6 months, or any permanent neurologic defect attributed to CVA.

15. Presence of one or more co-morbidities which reduces life expectancy to less than 12 months or may interfere with protocol study processes.

16. Known allergy to protocol-required concomitant medications including aspirin; clopidogrel, prasugrel, and ticagrelor; heparin and bivalirudin; or iodinated contrast that cannot be adequately pre-medicated.

17. Patient is participating in any other investigational drug or device clinical trial that has not reached its primary endpoint.

18. Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before treatment).

1. The presence of any non-study lesion in the target vessel with angiographic diameter stenosis >50%, or any additional target vessel stenosis which requires PCI either during or within 12 months after the study procedure

2. Left main diameter stenosis ≥30% or left main PCI planned.

3. Study target lesion in a bypass graft

4. Ostial RCA study target lesion

5. Chronic total occlusion (TIMI flow 0/1) study target lesion

6. Bifurcation study lesion with a planned dual stent strategy

7. In-stent restenosis study target lesion

8. 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiovascular Research Foundation, New York

OTHER

Sponsor Role: collaborator

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ziad Ali, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia Presbyterian Medical Center (NY)

Gregg W Stone, MD

Role: STUDY_CHAIR

Columbia Presbyterian Medical Center (NY)

Locations

University Hospital - Univ. of Alabama at Birmingham (UAB)

Birmingham, Alabama, United States

Scottsdale Healthcare Shea

Scottsdale, Arizona, United States

University of California at San Diego (UCSD) Medical Center

San Diego, California, United States

Heart Institute of Colorado

Broomfield, Colorado, United States

Orlando Health

Orlando, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Kansas University Medical Center

Kansas City, Kansas, United States

University of Massachusetts Medical Center

Worcester, Massachusetts, United States

New York Presbyterian Hospital/Columbia University

New York, New York, United States

Lenox Hill Hospital

New York, New York, United States

St. Francis Hospital

Roslyn, New York, United States

Eastern Cardiology

Greenville, North Carolina, United States

INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, United States

St. Charles Medical Center

Bend, Oregon, United States

Austin Heart

Austin, Texas, United States

Memorial Hermann Hospital

Houston, Texas, United States

The University of Texas Health Science at San Antonio

San Antonio, Texas, United States

Onze-Lieve-Vrouwziekenhuis Campus Aalst

Aalst, East Flanders, Belgium

Klinikum der Justus-Liebig-Universität

Giessen, Hesse, Germany

Ospedale Papa Giovanni XXIII

Bergamo, Lombardy, Italy

Centro Cardiologico Monzino

Milan, Lombardy, Italy

Kobe University Hospital

Chuo-ku, Hyōgo, Japan

Nara Medical University Hospital

Kashihara-shi, Nara, Japan

Osaka Saiseikai Nakatsu Hospital

Osaka, Osaka, Japan

Wakayama Medical University Hospital

Wakayama, Wakayama, Japan

Yamaguchi University Hospital

Ube-shi, Yamaguchi, Japan

Erasmus MC - Thoraxcenter

Rotterdam, South Holland, Netherlands

Hospital Universitario de la Princesa

Madrid, , Spain

Kings College Hospital

Brixton, London, United Kingdom

Countries

United States; Belgium; Germany; Italy; Japan; Netherlands; Spain; United Kingdom

References

Ali ZA, Karimi Galougahi K, Maehara A, Shlofmitz RA, Fabbiocchi F, Guagliumi G, Alfonso F, Akasaka T, Matsumura M, Mintz GS, Ben-Yehuda O, Zhang Z, Rapoza RR, West NEJ, Stone GW. Outcomes of optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation: one-year results from the ILUMIEN III: OPTIMIZE PCI trial. EuroIntervention. 2021 Jan 20;16(13):1085-1091. doi: 10.4244/EIJ-D-20-00498.

Reference Type: DERIVED

PMID: 32540793 (View on PubMed)

Ali ZA, Maehara A, Genereux P, Shlofmitz RA, Fabbiocchi F, Nazif TM, Guagliumi G, Meraj PM, Alfonso F, Samady H, Akasaka T, Carlson EB, Leesar MA, Matsumura M, Ozan MO, Mintz GS, Ben-Yehuda O, Stone GW; ILUMIEN III: OPTIMIZE PCI Investigators. Optical coherence tomography compared with intravascular ultrasound and with angiography to guide coronary stent implantation (ILUMIEN III: OPTIMIZE PCI): a randomised controlled trial. Lancet. 2016 Nov 26;388(10060):2618-2628. doi: 10.1016/S0140-6736(16)31922-5. Epub 2016 Oct 30.

Reference Type: DERIVED

PMID: 27806900 (View on PubMed)

Other Identifiers

SJM-CIP-10034

Identifier Type: -

Identifier Source: org_study_id