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NCT03551496 · ClinicalTrials.gov registry record · Phase 3

The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia

A Phase 3 study, sponsored by Boston Scientific Corporation.

Completed
Registry status
Phase 3
Development phase
201
Enrollment target

NCT03551496 is a Phase 3 study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 201 participants.

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The verdict

NCT03551496, a Phase 3 study, has completed, sponsored by Boston Scientific Corporation.

COMPLETED
Registry status
Phase 3
Development phase
201 participants
Enrollment target

Study Summary

Single phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs. percutaneous transluminal angioplasty (PTA).

Interventions

  • COMBINATION_PRODUCT Drug Eluting Stent - Below the Knee
  • DEVICE Standard PTA Control Arm

Trial Details

FieldValue
Enrollment Target 201 participants
Start Date 2018-08-31
Est. Completion 2023-12-20
Phase Phase 3

Sponsor

Boston Scientific Corporation

280 total trials

What the Registry Record Tells You About NCT03551496

The ClinicalTrials.gov registry entry for NCT03551496 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 201 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Drug Eluting Stent - Below the Knee is the first listed.

NCT03551496 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03551496 about?

NCT03551496 is a clinical study titled "The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia". Single phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs. percutaneous transluminal angioplasty (PTA).

What is the current status of trial NCT03551496?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 201 participants. The study started on 2018-08-31. Estimated completion is 2023-12-20.

What interventions are being tested in trial NCT03551496?

The interventions under investigation include: Drug Eluting Stent - Below the Knee (COMBINATION_PRODUCT), Standard PTA Control Arm (DEVICE).

Who is sponsoring clinical trial NCT03551496?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.