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NCT03875651 · ClinicalTrials.gov registry record

A Clinical Trial to Confirm Safety & Effectiveness of the SYNERGY 4.50 mm and 5.00 mm Stent for Treatment of Atherosclerotic Lesion(s)

A clinical trial, sponsored by Boston Scientific Corporation.

Completed
Registry status
100
Enrollment target

NCT03875651: Completed study, sponsored by Boston Scientific Corporation.

NCT03875651 is a clinical trial that has completed, run by Boston Scientific Corporation. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03875651 has completed, sponsored by Boston Scientific Corporation.

COMPLETED
Registry status
100 participants
Enrollment target

Study Summary

EVOLVE 4.5/5.0 is a prospective, single-arm, multi-center observational (standard of care) trial intended to confirm the safety and effectiveness of the SYNERGY 4.50 mm and 5.00 mm Coronary Stent System for the treatment of patients with coronary artery disease in large vessels (≤ 28 mm in length, by visual estimate, in native coronary arteries \> 4.00 mm to ≤5.00 mm in diameter, by visual estimate). This Post Approval study is a cohort associated with the SYNERGY MEGATRON Post Approval Study, which is registered under ClinicalTrials.gov ID: NCT04807439.

Primary Outcome

12-month Target Lesion Failure (TLF) rate, defined as any ischemia driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.

Interventions

  • DEVICE SYNERGY 4.50 mm and 5.0 mm Coronary Stent System

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2019-05-09
Est. Completion 2023-11-28
Boston Scientific Corporation

280 total trials

What the finished NCT03875651 record still lists

NCT03875651 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which SYNERGY 4.50 mm and 5.0 mm Coronary Stent System is the first listed.

NCT03875651 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03875651 about?

NCT03875651 is a clinical study titled "A Clinical Trial to Confirm Safety & Effectiveness of the SYNERGY 4.50 mm and 5.00 mm Stent for Treatment of Atherosclerotic Lesion(s)". EVOLVE 4.5/5.0 is a prospective, single-arm, multi-center observational (standard of care) trial intended to confirm the safety and effectiveness of the SYNERGY 4.50 mm and 5.00 mm Coronary Stent System for the treatment of patients with coronary artery disease in large vessels (≤ 28 mm in length, b...

What is the current status of trial NCT03875651?

This trial is currently completed. The enrollment target is 100 participants. The study started on 2019-05-09. Estimated completion is 2023-11-28.

What interventions are being tested in trial NCT03875651?

The interventions under investigation include: SYNERGY 4.50 mm and 5.0 mm Coronary Stent System (DEVICE).

Who is sponsoring clinical trial NCT03875651?

This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03875651, the US trial registry maintained by the National Library of Medicine. NCT03875651 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.