Autopsy report · NCT03190473

OPTIMIZE IDE for the Treatment of ACS

“Company financial insolvency, not due to safety or efficacy concerns”

The sponsor’s own words in the registry.

Life of this trial

• Registered 7 months before it started.
• Ran for about 5 years 2 months before it stopped.
• 1,630 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Na

Sponsor

Svelte Medical Systems, Inc.

Sponsor type

Industry

Conditions

Acute Coronary Syndrome

Interventions

DES

Participants

1,630

Sites

72

Countries

Japan, Netherlands, United States

Trials that died the same way

• directSTIM™ Deep Brain Stimulation System Post-Market Clinical Follow-up Study on Essential Tremor
  “Insolvency of the business” (70% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.