Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon

Peripheral Arterial Disease Clinical Trial

— ILLUMENATE  

Official title:

ILLUMENATE Pivotal: ProspectIve, Randomized, SingLe-Blind, U.S. MuLti-Center Study to EvalUate TreatMent of Obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel PacliTaxel-CoatEd Percutaneous Angioplasty Balloon

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858428
• Other study ID #: TP-1397
• Status: Completed
• Phase: N/A
• Start date: June 18, 2013
• Est. completion date: March 19, 2018

Study information

• Verified date: August 2020
• Source: Spectranetics Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the safety and efficacy of a Paclitaxel-coated percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with peripheral arterial disease.

Description:

The ILLUMENATE Pivotal study is a prospective, randomized, multi-center, single-blind study which will include up to 360 subjects in approximately forty-five (45) sites across the United States to evaluate the CVI Paclitaxel-coated PTA Catheter compared to the bare percutaneous transluminal angioplasty balloon catheter (bare balloon catheter) for the treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for in-stent) SFA and/or popliteal arteries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 19, 2018
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with symptomatic leg ischemia, requiring treatment of the Superficial Femoral Artery (SFA) or popliteal artery.

Exclusion Criteria:

• Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.
• EverCross Percutaneous Transluminal Balloon Catheter
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA).

Locations

Country	Name	City	State
Austria	LKH Univ. - Klinikum Graz	Graz
Austria	Hanusch Krankenhaus Wien	Vienna
United States	Mission Hospital	Asheville	North Carolina
United States	Emory University Hospital	Atlanta	Georgia
United States	Northside Hospital	Atlanta	Georgia
United States	Heritage Valley Health System	Beaver	Pennsylvania
United States	Deborah Heart and Lung Center	Browns Mills	New Jersey
United States	CAMC Clinical Trial Center	Charleston	West Virginia
United States	University of Virginia	Charlottesville	Virginia
United States	University Surgical Associates	Chattanooga	Tennessee
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Providence Cardiology LLC	Columbia	South Carolina
United States	OhioHealth Research Institute	Columbus	Ohio
United States	Texas Health & Research Education Institution	Dallas	Texas
United States	Central Iowa Hospital Corporation	Des Moines	Iowa
United States	El Paso Cardiology Associates	El Paso	Texas
United States	North Ohio Research LTD.	Elyria	Ohio
United States	St. Joseph Hospital	Fort Wayne	Indiana
United States	Mission Cardiovascular Research Institute	Fremont	California
United States	Cardiovascular Research of North Florida	Gainesville	Florida
United States	University of Texas Health Science Center	Houston	Texas
United States	Jackson Heart Clinic	Jackson	Mississippi
United States	Wellmont Holston Area Medical Center	Kingsport	Tennessee
United States	Premier Surgical Associates	Knoxville	Tennessee
United States	Good Samaritan Hospital - Los Angeles	Los Angeles	California
United States	Medical Center of the Rockies	Loveland	Colorado
United States	Baptist Cardiac and Vascular Institute	Miami	Florida
United States	Aurora Health Care	Milwaukee	Wisconsin
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Mount Sinai Medical Center	New York	New York
United States	Sentara Vascular Specialist	Norfolk	Virginia
United States	Advocate Health and Hospitals Corporation	Oakbrook Terrace	Illinois
United States	Oklahoma Foundation for Cardiovascular Research	Oklahoma City	Oklahoma
United States	Coastal Vascular and Interventional	Pensacola	Florida
United States	Cardiac & Vascular Research Center of Northern Michigan	Petoskey	Michigan
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Providence Heart and Vascular Institute	Portland	Oregon
United States	Rex Hospital	Raleigh	North Carolina
United States	Wake Heart Research	Raleigh	North Carolina
United States	Sanford Health Vascular Associates	Sioux Falls	South Dakota
United States	Jobst Vascular Institute	Toledo	Ohio
United States	Pinnacle Health Cardiovascular Institute, INC.	Wormleysburg	Pennsylvania
United States	Metro Health Hospital	Wyoming	Michigan
United States	Yuma Regional Medical Center	Yuma	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Spectranetics Corporation

Countries where clinical trial is conducted

United States,  Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency at 12 Month Post-procedure	Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) = 2.5) and freedom from clinically-driven target lesion revascularization.	12 months
Primary	Freedom From Device and Procedure-related Death and Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization	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 through 12 months post-procedure.	30 Days and 12 months
Secondary	Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure	Major adverse event (MAE) rate in the hospital and at 1, 6, 12, 24, 36, 48 and 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).	1, 6, 12, 24, 36, 48 and 60 months
Secondary	Rate of Vascular Access and Bleeding Complications	Rate of vascular access and bleeding complications in the hospital and at 1, 6, 12 and 24 months.	in-hospital and 1, 6, 12 and 24 months
Secondary	Rate of Clinically-driven Target Lesion Revascularization		6, 12, 24, 36, 48 and 60 months
Secondary	Rate of Target Lesion Revascularization		6, 12, 24, 36, 48 and 60 months
Secondary	Rate of Target Limb Major Amputation		1, 6, 12, 24, 36, 48 and 60 months
Secondary	Mortality Rate		6, 12, 24, 36, 48 and 60 months
Secondary	Rate of Occurrence of Arterial Thrombosis of the Treated Segment		1, 6, 12, 24, 36, 48 and 60 months
Secondary	Patency Rate and Freedom From Clinically-driven TLR	Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR = 2.5) and freedom from clinically-driven TLR at 6, 24 and 36 months	6, 24 and 36 months
Secondary	Lesion Success of Achieving a Final In-lesion Residual Diameter Stenosis of =50%	Lesion success, defined as achievement of a final in-lesion residual diameter stenosis of =50% (as determined by the angiographic core lab), using any device after wire passage through the lesion.	procedure, Day 0
Secondary	Technical Success of Achieving a Final In-lesion Residual Diameter Stenosis of =50%	Technical success, defined as achievement of a final in-lesion residual diameter stenosis of =50% (as determined by the angiographic core lab), using the CVI Paclitaxel-coated PTA Catheter or bare balloon catheter without a device malfunction after wire passage through the lesion.	procedure, Day 0
Secondary	Per Subject Clinical Success Achieving no Major Adverse Events During the Procedure	Clinical success (per subject) defined as technical success without the occurrence of major adverse events during the procedure.	procedure, Day 0
Secondary	Per Subject Procedural Success Achieving no Major Adverse Events During the Procedure	Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during the procedure.	procedure, Day 0
Secondary	Change in Ankle-brachial Index (ABI) From Pre-procedure	Subjects who had reinterventions were included in ABI analyses so some improvements may be reflective of revascularizations during the follow-up period.	6, 12, 24 and 36 months