Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

Prospective, Randomized, Multi-Center Study to Evaluate Treatment of Subjects With Occlusive Disease With a Novel Paclitaxel-Coated Angioplasty Balloon in Below-The-Knee (BTK) Arteries

Status

Suspended

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03175744

Acronym

ILLUMENATE-BTK

Enrollment

Registered

2017-06-05

Start date

2017-05-24

Completion date

2025-10-31

Last updated

2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Limb Ischemia

Brief summary

The purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the treatment of stenosis or occlusions of below-the-knee arteries.

Interventions

DEVICEStellarex DCB

Intervention with the Stellarex DCB

DEVICEPTA Catheter

Intervention with an uncoated Standard PTA

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Rutherford Clinical Category 4-5 * Life expectancy \> 1 year * Significant stenosis ≥70% * Patent inflow artery * Target vessel(s) diameter between 2 and 4 mm * Target vessel(s) reconstitute(s) at the ankle

Exclusion criteria

* Pregnant or planning to become pregnant * History of stroke within 3 months * Planned major amputation * eGFR \<30 * Acute limb ischemia * Prior stent placement in target lesion

Design outcomes

Primary

Measure	Time frame	Description
Freedom from Major Adverse Limb Event (MALE)	30 days	Composite of major amputation or major reintervention on a per patient basis
Freedom from Perioperative Death (POD)	30 days	Death on a per patient basis
Patency	6 months	Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis
Limb Salvage	6 months	Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis

Secondary

Measure	Time frame	Description
Major adverse event rates	6 months	Composite rate of all-cause death, major amputation and clinically driven target lesion reintervention
Patency rate	6 months	Absence of target lesion occlusion and freedom from clinically-driven target lesion reintervention
Clinically-driven target lesion revascularization	6 months	Rate of clinically-driven target lesion revascularization

Countries

Australia, Austria, Belgium, Germany, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026