Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon

NCT01858428 | Completed Results DMC

• 1 other identifier: TP-1397
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 44

Brief 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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (13)

• Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure

  1, 6, 12, 24, 36, 48 and 60 months

• Rate of Vascular Access and Bleeding Complications

  in-hospital and 1, 6, 12 and 24 months

• Rate of Clinically-driven Target Lesion Revascularization

  6, 12, 24, 36, 48 and 60 months

• Rate of Target Lesion Revascularization

  6, 12, 24, 36, 48 and 60 months

• Rate of Target Limb Major Amputation

  1, 6, 12, 24, 36, 48 and 60 months

Study Arms (2)

Bare PTA

ACTIVE COMPARATOR

The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA).

Device: EverCross Percutaneous Transluminal Balloon Catheter

Drug-Coated PTA

EXPERIMENTAL

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.

Device: Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter

Interventions

Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter DEVICE

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.

Drug-Coated PTA

EverCross Percutaneous Transluminal Balloon Catheter DEVICE

The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA).

Bare PTA

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Spectranetics Corporation: lead

Study Sites (44)

Yuma Regional Medical Center

Yuma, Arizona, 85364, United States

Location

Mission Cardiovascular Research Institute

Fremont, California, 94538, United States

Location

Good Samaritan Hospital - Los Angeles

Los Angeles, California, 90017, United States

Location

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Cardiovascular Research of North Florida

Gainesville, Florida, 32605, United States

Location

Baptist Cardiac and Vascular Institute

Miami, Florida, 33176, United States

Location

Coastal Vascular and Interventional

Pensacola, Florida, 32504, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Advocate Health and Hospitals Corporation

Oakbrook Terrace, Illinois, 60181, United States

Location

St. Joseph Hospital

Fort Wayne, Indiana, 46802, United States

Location

Central Iowa Hospital Corporation

Des Moines, Iowa, 50309, United States

Location

Cardiac & Vascular Research Center of Northern Michigan

Petoskey, Michigan, 49770, United States

Location

Metro Health Hospital

Wyoming, Michigan, 15146, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

Wake Heart Research

Raleigh, North Carolina, 27607, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

OhioHealth Research Institute

Columbus, Ohio, 43214, United States

Location

North Ohio Research LTD.

Elyria, Ohio, 44035, United States

Location

Jobst Vascular Institute

Toledo, Ohio, 43606, United States

Location

Oklahoma Foundation for Cardiovascular Research

Oklahoma City, Oklahoma, 73120, United States

Location

Providence Heart and Vascular Institute

Portland, Oregon, 97225, United States

Location

Heritage Valley Health System

Beaver, Pennsylvania, 15009, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Pinnacle Health Cardiovascular Institute, INC.

Wormleysburg, Pennsylvania, 17043, United States

Location

Providence Cardiology LLC

Columbia, South Carolina, 29204, United States

Location

Sanford Health Vascular Associates

Sioux Falls, South Dakota, 57117, United States

Location

University Surgical Associates

Chattanooga, Tennessee, 37403, United States

Location

Wellmont Holston Area Medical Center

Kingsport, Tennessee, 37660, United States

Location

Premier Surgical Associates

Knoxville, Tennessee, 37909, United States

Location

Texas Health & Research Education Institution

Dallas, Texas, 75231, United States

Location

El Paso Cardiology Associates

El Paso, Texas, 79902, United States

Location

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Sentara Vascular Specialist

Norfolk, Virginia, 23507, United States

Location

CAMC Clinical Trial Center

Charleston, West Virginia, 25304, United States

Location

Aurora Health Care

Milwaukee, Wisconsin, 53215, United States

Location

LKH Univ. - Klinikum Graz

Graz, Austria

Location

Hanusch Krankenhaus Wien

Vienna, Austria

Location

Related Publications (4)

• Krishnan P, Faries P, Niazi K, Sachar R, Jain A, Brodmann M, Werner M, Holden A, Tarricone A, Tarra T, Lyden S. Stellarex Drug-Coated Balloon for the Treatment of Peripheral Artery Disease: Five-Year Results from the ILLUMENATE Pivotal Randomized Controlled Trial. Am J Cardiol. 2024 Sep 15;227:83-90. doi: 10.1016/j.amjcard.2024.06.027. Epub 2024 Jul 15.

  PMID: 39019203 DERIVED

• 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

• Krishnan P, Faries P, Niazi K, Jain A, Sachar R, Bachinsky WB, Cardenas J, Werner M, Brodmann M, Mustapha JA, Mena-Hurtado C, Jaff MR, Holden AH, Lyden SP. Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease: Twelve-Month Outcomes From the Randomized ILLUMENATE Pivotal and Pharmacokinetic Studies. Circulation. 2017 Sep 19;136(12):1102-1113. doi: 10.1161/CIRCULATIONAHA.117.028893. Epub 2017 Jul 20.

  PMID: 28729250 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Limitations and Caveats

Per FDA confirmation letter, dated April 10, 2018, Re: G120270/R012, this study concluded March 19, 2018. Subjects rolled into the post-approval study (NCT03421561). Long-term follow-up data can be found there for remaining study objectives.

Results Point of Contact

• Title: Julie Wolfram Smith
• Organization: Spectranetics

julie.wolframsmith@spnc.com

763-955-1072

Study Officials

• Prakash Krishnan, MD

  Mt. Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Sean Lyden, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• 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: June 18, 2013
• Primary Completion: September 1, 2016
• Study Completion: March 19, 2018
• Last Updated: August 24, 2020
• Results First Posted: January 17, 2018

Record last verified: 2020-08

Locations

AU (2); US (42)