NCT01927068

STELLAREX: ILLUMENATE Global and In-Stent Restenosis (ISR)

Prospective, Single-Arm, Global Multi-Center Study to Evaluate Treatment of Obstructive Superficial Femoral Artery (SFA) and/or Popliteal Lesions With a Novel Paclitaxel-Coated Percutaneous Angioplasty (PTA) Balloon and in In-Stent Restenosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 499 (actual)
• Sponsor: Spectranetics Corporation · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Cohort 1: Single-Arm, multicenter study to continue to assess the safety and performance of the Stellarex 035 Drug Coated Balloon (formerly known as the Cardiovascular Ingenuity (CVI) Paclitaxel-Coated PTA Balloon Catheter) in the treatment of de novo or restenotic lesions in the superficial femoral and/or popliteal arteries. Cohort 2: To evaluate this patient population for treatment of in-stent restenotic lesions.

Detailed description

Cohort 1: The purpose of this single arm study is to continue to assess safety and performance of the Stellarex 035 DCB in the treatment of de novo or restenotic lesions in the superficial femoral (SFA) and/or popliteal arteries. Cohort 2: A second cohort is being added to evaluate this patient population for treatment of in-stent restenotic lesions. Cohort 1: Prospective, multi-center, single-arm study. Cohort 2: Prospective, multi-center, single-arm study compared to a historical control. Cohort 1: Follow-up assessments will occur at discharge, 1 month, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months following the study procedure. Cohort 2: Follow-up assessments will occur at discharge, 1 month, 6 months, 12 months, 24 months and 36 months following the study procedure.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB)	Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute.

Timeline

• Start date: 2013-07-01
• Primary completion: 2020-08-01
• Completion: 2022-08-01
• First posted: 2013-08-22
• Last updated: 2023-03-24
• Results posted: 2022-03-15

Locations

44 sites across 10 countries: Australia, Austria, Belgium, France, Germany, Italy, New Zealand, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated device study