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Drug-Eluting Stent

DES for Acute Coronary Syndrome (OPTIMIZE Trial)

N/A

Waitlist Available

Research Sponsored by Svelte Medical Systems, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 months, and annually through 5 years

Awards & highlights

OPTIMIZE Trial Summary

This trial is for a new type of stent that is used to improve coronary luminal diameter in patients with heart disease.

OPTIMIZE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 months, and annually through 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12 months, and annually through 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months, and annually through 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Target Lesion Failure (TLF)

Secondary outcome measures

Major Adverse Cardiac Event (MACE)

Stent Thrombosis

Target Vessel Failure (TVF)

OPTIMIZE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SvelteExperimental Treatment1 Intervention

Group II: ControlActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DES

2017

N/A

~80

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Svelte Medical Systems, Inc.Lead Sponsor

3 Previous Clinical Trials

611 Total Patients Enrolled

1 Trials studying Acute Coronary Syndrome

12 Patients Enrolled for Acute Coronary Syndrome

Dennis Donohoe, MDStudy DirectorSvelte Medical

2 Previous Clinical Trials

452 Total Patients Enrolled

1 Trials studying Acute Coronary Syndrome

12 Patients Enrolled for Acute Coronary Syndrome

Shing C Wong, MDStudy DirectorSvelte Medical

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for patients to become participants in this clinical investigation?

"This clinical trial is not presently enrolling, as evidenced by the last update to its listing on clinicialtrials.gov dated May 25th 2022. Despite this, there are still 136 other studies that require participants at present."

Answered by AI

How many locations are participating in this experiment?

"Currently, there are 54 medical centres offering this trial. These locations encompass Seattle, Miami and Raleigh in addition to 51 other sites spread out across the United States. To reduce travel demands, patients should choose a location nearby for enrollment."

Answered by AI

Recent research and studies

Circulation: Cardiovascular InterventionsJournal

Safety and Effectiveness of the SVELTE Fixed-wire and Rapid Exchange Bioresorbable-polymer Sirolimus-eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions: Results of the OPTIMIZE Randomized Study

Kereiakes, Dean J., Robert L. Feldman, A.J.J. Ijsselmuiden, Shigeru Saito, Giovanni Amoroso, James P. Zidar, S. Chiu Wong, et al.. 2021. “Safety and Effectiveness of the SVELTE Fixed-wire and Rapid Exchange Bioresorbable-polymer Sirolimus-eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions: Results of the OPTIMIZE Randomized Study”. Circulation: Cardiovascular Interventions. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circinterventions.121.010609.

American Heart JournalJournal

The OPTIMIZE Randomized Trial to Assess Safety and Efficacy of the Svelte IDS and RX Sirolimus-eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions: Trial Design and Rationale

Mauri, Laura, Gheorghe Doros, Sunil V. Rao, David J. Cohen, Steven Yakubov, John Lasala, S. Chiu Wong, James Zidar, and Dean J. Kereiakes. 2019. “The OPTIMIZE Randomized Trial to Assess Safety and Efficacy of the Svelte IDS and RX Sirolimus-eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions: Trial Design and Rationale”. American Heart Journal. Elsevier BV. doi:10.1016/j.ahj.2019.07.003.

Circulation: Cardiovascular InterventionsJournal

clinicaltrials.govStudy

OPTIMIZE IDE for the Treatment of ACS

2018. "OPTIMIZE IDE for the Treatment of ACS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03190473.