Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2025-12-28 @ 7:57 AM
Study NCT ID:
NCT01927068
Status:
COMPLETED
Last Update Posted:
2023-03-24
First Post:
2013-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
STELLAREX: ILLUMENATE Global and In-Stent Restenosis (ISR)
Sponsor:
Spectranetics Corporation
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ILLUMENATE
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CP-1005B | OTHER | Spectranetics | View |