ILLUMENATE EU Randomized Clinical Trial

NCT01858363 | Completed Results DMC

• 1 other identifier: TP 1360
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, multi-center, single-blind study to demonstrate the safety and effectiveness of the CVI Paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon versus bare PTA balloon for the treatment of patients with de novo occluded/stenotic or reoccluded/restenotic lesions of the superficial femoral (SFA) and popliteal arteries.

Conditions

Peripheral Arterial Disease; Claudication

Keywords

Peripheral arterial disease; claudication; drug-coated balloon; drug-eluting balloon

Outcome Measures

Primary Outcomes (2)

• Patency at 12-months

  The primary efficacy endpoint was patency at 12 months post-procedure defined as the absence of target lesion restenosis determined by duplex ultrasound peak systolic velocity ratio (PSVR) ≤2.5 and freedom from clinically-driven target lesion revascularization (CD-TLR).

  12 months

• Percentage of Patients With Freedom From Device and Procedure Related Target Limb Major Amputation or Death Through 30-days Post-procedure and Clinically-driven Target Lesion Revascularization at 12-month

  The primary safety endpoint was freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) through 12 months post-procedure.

  30-Days and 12-Months

Study Arms (2)

Paclitaxel-coated balloon

EXPERIMENTAL

Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon.

Device: CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter

Bare balloon

PLACEBO COMPARATOR

Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon.

Device: Bare Percutaneous Transluminal Angioplasty Balloon Catheter

Interventions

CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter DEVICE

Paclitaxel-coated balloon

Bare Percutaneous Transluminal Angioplasty Balloon Catheter DEVICE

Bare balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic leg ischemia requiring treatment of the superficial femoral or popliteal arteries
• Rutherford clinical category 2, 3 or 4
• Male or non-pregnant female at least 18 years

You may not qualify if:

• Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries
• Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
• Known intolerance of study medications, paclitaxel or contrast agent
• Active participation in another investigational device or drug study

Sponsors & Collaborators

• Spectranetics Corporation: lead

Study Sites (1)

Center for Diagnostic Radiology and Minimally Invasive Therapy

Berlin, Germany

Location

Related Publications (4)

• Schroeder H, Werner M, Meyer DR, Reimer P, Kruger K, Jaff MR, Brodmann M; ILLUMENATE EU RCT Investigators. Low-Dose Paclitaxel-Coated Versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease: One-Year Results of the ILLUMENATE European Randomized Clinical Trial (Randomized Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon). Circulation. 2017 Jun 6;135(23):2227-2236. doi: 10.1161/CIRCULATIONAHA.116.026493. Epub 2017 Apr 19.

  PMID: 28424223 RESULT

• Brodmann M, Werner M, Meyer DR, Reimer P, Kruger K, Granada JF, Jaff MR, Schroeder H; ILLUMENATE EU RCT Investigators. Sustainable Antirestenosis Effect With a Low-Dose Drug-Coated Balloon: The ILLUMENATE European Randomized Clinical Trial 2-Year Results. JACC Cardiovasc Interv. 2018 Dec 10;11(23):2357-2364. doi: 10.1016/j.jcin.2018.08.034.

  PMID: 30522663 RESULT

• Lyden SP, Brodmann M, Parikh SA, Krishnan P, Schroeder H, Werner M, Holden A, Ouriel K, Tarra T, Gray WA. Four-year patient-level pooled mortality analysis of the ILLUMENATE US Pivotal and EU randomized controlled trials. J Vasc Surg. 2022 Feb;75(2):600-607. doi: 10.1016/j.jvs.2021.07.244. Epub 2021 Sep 8.

  PMID: 34506898 DERIVED

• Gray WA, Jaff MR, Parikh SA, Ansel GM, Brodmann M, Krishnan P, Razavi MK, Vermassen F, Zeller T, White R, Ouriel K, Adelman MA, Lyden SP. Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years. Circulation. 2019 Oct;140(14):1145-1155. doi: 10.1161/CIRCULATIONAHA.119.040518. Epub 2019 Sep 30.

  PMID: 31567024 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nicolas Aguirre
• Organization: Spectranetics

nicolas.aguirre@philips.com

+1-312-297-6655

Study Officials

• Henrik Schroeder, M.D.

  Center for Diagnostic Radiology & Minimally Invasive Therapy, The Jewish Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 21, 2013
• Study Start: November 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: October 1, 2020
• Last Updated: October 13, 2021
• Results First Posted: October 13, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)