Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2025-12-24 @ 5:51 PM
NCT ID:
NCT01927068
Brief 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.
Study:
NCT01927068
Study Brief:
Protocol Section:
NCT01927068