CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 201 enrolled
Drug / intervention
Drug Eluting Stent - Below the Knee +1 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03551496
NCT03551496Phase 3Completed
CompareCT.gov

A Randomized Trial Comparing the Drug-Eluting Stent (DES) Below-the-Knee (BTK) Vascular Stent System (DES BTK Vascular Stent System) vs Percutaneous Transluminal Angioplasty (PTA) Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia

Boston Scientific Corporation·interventional·Posted Jun 11, 2018·Updated Jul 1, 2024

In Brief

A Phase 3 clinical trial evaluating Drug Eluting Stent - Below the Knee and Standard PTA Control Arm for Critical Limb Ischemia. Completed, enrolled 201 participants across 42 sites in 5 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritical Limb Ischemia
CountriesBelgium, France, Japan, Netherlands, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJun 11, 2018
Enrollment StartAug 31, 2018
Primary CompletionApr 21, 2022
Study CompletionDec 20, 2023
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 8.1 years ago

Interventions

Drug Eluting Stent - Below the Kneecombination

Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm

Standard PTA Control Armdevice

The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.