NCT03395236

ILLUMENATE Below-The-Knee (BTK) Arteries: a Post Market Clinical Study

ProspectIve, MuLti-Center Study to EvaLUate TreatMent of Subjects With OcclusivE Disease With a Novel PAcliTazel-CoatEd Angioplasty Balloon in Below-The-Knee (BTK) Arteries: a Post Market Clinical Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Spectranetics Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the StellarexTM 0.014" OTW Drug-coated Angioplasty Balloon in the treatment of lesions in "below the knee" popliteal (P3 segment) and infra-popliteal arteries according to the Instructions for Use in Rutherford-Becker Classification (RCC) 3, 4 and 5 patient populations. This study will be conducted in Europe across up to 10 centers in up to 75 subjects. Office visits will occur at 30 days, 6, 12, and 24 months post-index procedure.

Detailed description

There is a significant amount of evidence that the use of Paclitaxel-coated balloons in the treatment of peripheral arterial disease (PAD) has demonstrated favorable outcomes when used to treat lesions in the superficial femoral and popliteal arteries. For subjects with lesions in the infrapopliteal arteries, which includes lesions in the mid to distal popliteal artery and below, a smaller profile balloon is necessary. Typically, lesions in the SFA and proximal popliteal arteries are treated by larger diameter balloons and larger sized guidewires (most commonly 0.018" or 0.035") which are too large for vessels below-the-knee. For this reason, the Stellarex™ 0.014" OTW Drug-coated Angioplasty Balloon was developed as a line extension to the Stellarex™ 0.035" device in order to accommodate the treatment of these smaller vessels. The Stellarex™ 0.014" balloon has the same drug concentration and is manufactured using a similar method as the Stellarex™ 0.035" device. Additionally, the Stellarex™ 0.035" and 0.014" balloon share a common balloon diameter of 4 mm, a size which was used to treat lesions throughout the popliteal artery in the previous Stellarex 0.035" studies. For the reasons noted above, equivalence between the two devices has been demonstrated. Furthermore, it is believed that the 0.014" device will not demonstrate any performance differences nor change the anticipated or residual risks. In conclusion, the current study has been developed in agreement with post-market requirements as per the Post Market Clinical Follow up (PMCF) plan. The prospective design of the study, the sample size and the selected outcomes will be able to provide the additional clinical information to support the safe use and performance of the Stellarex 0.014" device in the intended population of patients with below-the-knee arterial disease.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
COMBINATION_PRODUCT	StellarexTM 0.014" Over-The-Wire Drug-coated Angioplasty Balloon	The Stellarex balloon (0.014") is indicated for the treatment of de-novo or re-stenotic lesions in the lower extremities to establish blood flow and to maintain vessel patency.

Timeline

• Start date: 2018-04-20
• Primary completion: 2023-08-23
• Completion: 2023-08-23
• First posted: 2018-01-10
• Last updated: 2024-01-24

Locations

10 sites across 3 countries: Germany, Netherlands, United Kingdom

Regulatory

• FDA-regulated drug study
• FDA-regulated device study