STELLAREX: ILLUMENATE Global and In-Stent Restenosis (ISR)

NCT01927068 | Completed Results DMC FDA Device

• 2 other identifiers: CP-1005CP-1005B
• Study Type: interventional
• Target: 499
• Locations: 9 countries
• Sites: 38

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Freedom From Device and Procedure-related Death and Freedom From 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 (TLR) through 12 months post-procedure.

  Through 12 months post-procedure.

• Percentage of Lesions Free From Restenosis

  Primary patency at 12 months post-procedure. Primary patency is defined as the absence of target lesion restenosis per duplex ultrasound (peak systolic velocity ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.

  12 months post-procedure.

Secondary Outcomes (1)

• Secondary Efficacy Endpoint

  12 months post-procedure

Study Arms (2)

Global Cohort 1

EXPERIMENTAL

All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX).

Device: Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB)

ISR Cohort 2

EXPERIMENTAL

All subjects to be treated with the Stellarex 035 Drug Coated Balloon (DCB) for Percutaneous Transluminal Angioplasty (PTA).The drug coating is paclitaxel (PTX).

Device: Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB)

Interventions

Stellarex 0.035" Over-the-Wire (OTW) drug-coated angioplasty balloon (Stellarex DCB) DEVICE

Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute.

Also known as: CVI Paclitaxel-Coated PTA Balloon Catheter

Global Cohort 1; ISR Cohort 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has symptomatic leg ischemia, requiring treatment of the SFA and/or popliteal artery.
• Has a Rutherford Clinical Category of 2 - 4. Note: Rutherford Clinical Category 2 subjects should be entered into the study if conservative treatment has been unsuccessful.
• Is ≥18 years old.
• Has life expectancy \>1 year.
• Is able and willing to provide written informed consent prior to study specific procedures.
• Is willing and capable of complying with the required follow-up visits, testing schedule and medication regimen.
• Has evidence at the target lesion(s) of clinically and hemodynamically significant de novo stenosis or restenosis, or occlusion, in the SFA (1 cm distal to the ostium of the profunda) and/or popliteal artery (proximal to the popliteal trifurcation), confirmed by angiography.
• Has target limb with at least one patent (\<50% stenosis) tibio-peroneal run-off vessel to the foot confirmed by baseline angiography or magnetic resonance angiography (MRA) or computed tomography angiography (CTA). Note: Treatment of outflow disease is NOT permitted.
• Has 1 or 2 target lesion(s) with a cumulative lesion(s) length of no more than 20 cm. Note: A maximum of two (2) lesions can be treated if the cumulative total lesion length (i.e. the combined length of both lesions) is less than or equal to 20cm.
• Has target lesion(s) located \>2 cm from any stent if the target vessel was previously stented.
• Has a reference vessel diameter of 4 - 6 mm by visual estimate.
• Has a successful exchangeable guidewire crossing of the lesion(s).

You may not qualify if:

• A female who is pregnant, of childbearing potential not taking adequate contraceptive measures, or nursing; or a male intending to father children during the study.
• Has significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
• Has known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.
• Is currently participating in another investigational device or drug study that would interfere with study endpoints.
• Has history of hemorrhagic stroke within 3 months.
• Has surgical or endovascular procedure of the target limb within 14 days prior to the index procedure.
• Has any planned surgical intervention (requiring hospitalization) or endovascular procedure within 30 days after the index procedure.
• Has had a previous peripheral bypass affecting the target limb.
• Has unstable angina pectoris, myocardial infarction, liver failure, renal failure or chronic kidney disease (dialysis dependent, or serum creatinine ≥2.5 mg/dL) within 30 days of the index procedure.
• Has significant stenosis (≥50%) or occlusion of inflow tract that is not successfully revascularized (\<30% residual stenosis without death or major vascular complication) prior to treatment of the target lesion(s). Only treatment of target lesion(s) is acceptable after successful treatment of inflow iliac artery lesion(s).
• Has an acute or sub-acute intraluminal thrombus within the target vessel.
• Has in-stent restenosis or restenosis of the target lesion following previous treatment with a drug-coated balloon.
• Has an aneurysm (at least twice the reference vessel diameter) located in the target vessel, abdominal aorta, iliac, or popliteal arteries.
• Has perforation, dissection or other injury of the access or target vessel requiring stenting or surgical intervention prior to enrollment.
• Has no normal arterial segment proximal to the target lesion in which duplex ultrasound velocity ratios can be measured.

Sponsors & Collaborators

• Spectranetics Corporation: lead

Study Sites (44)

The Wesley St. Andrew Research Institute Ltd.

Auchenflower, Australia

Location

Flinders Medical Centre

Bedford, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, Australia

Location

Monash Medical Centre at Dandenong Campus

Dandenong, 3175, Australia

Location

The Alfred Hospital

Melbourne, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Australia

Location

Medizinische Universität Graz - Univ. Klinik für Innere Medizin

Graz, 8036, Austria

Location

Onze Lieve Vrouw Ziekenhuis

Aalst, 9300, Belgium

Location

Middelheim Hospital

Antwerp, Belgium

Location

Imelda Hospital

Bonheiden, 2820, Belgium

Location

AZ Sint-Blasius

Dendermonde, 9200, Belgium

Location

ZOL Campus Sint Jan

Genk, 3600, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, Belgium

Location

University Clinic Leuven

Leuven, Belgium

Location

Regionaal Ziekenhuis Heilig Hart Tienen, Campus Mariëndal - MCT, Vascular Surgery Department

Tienen, Belgium

Location

CHU de Clermont-Ferrand, Hôpital Gabriel Montpied

Clermont-Ferrand, France

Location

CHU de Lyon, Hôpital Edouard Herriot

Lyon, France

Location

Hopital de Ia Timone

Marseille, France

Location

CHU de Nantes, Hôpital Nord Laennec

Nantes, France

Location

Hôpital Européen georges Pompidou

Paris, France

Location

CHU de Rennes, Hôpital Pontchaillou

Rennes, France

Location

Clinique Pasteur

Toulouse, France

Location

Universitats-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Germany

Location

Jüdisches Krankenhaus Berlin

Berlin, 3347, Germany

Location

Medizinische Universitätsklinik III

Heidelberg, Germany

Location

Klinikum Immenstadt, Herz-und Gefässzentrum Oberallgäu-Kempten

Immenstadt im Allgäu, Germany

Location

SRH Klinikum Karlsbad-Langensteinbach

Langensteinbach, 76307, Germany

Location

University Leipzig Medical Center

Leipzig, Germany

Location

RoMed Klinikum Rosenheim

Rosenheim, 83022, Germany

Location

Universitatsklinik, Abteilung Für Diagnostische und Inverventionelle Radiologie

Tübingen, Germany

Location

Ospedali Riuniti - SOD

Ancona, Italy

Location

Villa Maria Eleonora Hospital

Palermo, Italy

Location

S.C. Chirurgia Vascolare ed Endovascolare

Perugia, Italy

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Middlemore Hospital

Auckland, 2015, New Zealand

Location

Waikato Hospital

Hamilton, 3240, New Zealand

Location

Wellington Hospital

Wellington, New Zealand

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Location

Instytut Hematologii i Transfuzjologii

Warsaw, Poland

Location

Centre d'Atencio Integral Hospital Dos de Maig

Barcelona, Spain

Location

Hospital Universitario Quirón de Madrid

Madrid, Spain

Location

Imperial College Academic and Healthcare NHS Trust, St. Mary's Hospital

London, United Kingdom

Location

King's College

London, United Kingdom

Location

UCL Division of Surgery and Interventional Science

London, United Kingdom

Location

Related Publications (1)

• 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

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Associate Director, Clinical Operations
• Organization: Spectranetics LLC, now part of Philips Image Guided Therapy

nicolas.aguirre@philips.com

612-297-6655

Study Officials

• Thomas Zeller, MBChB, FRANZCR

  Herz-Zentrum Bad Krozingen, Germany

  PRINCIPAL INVESTIGATOR

• Andrew Holden, MD

  Auckland Hospital, New Zealand

  PRINCIPAL INVESTIGATOR

• Yann Goueffic, MD

  Hopital Nord Laennec, France

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2013
• First Posted: August 22, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2022
• Last Updated: March 24, 2023
• Results First Posted: March 15, 2022

Record last verified: 2023-03

Locations

AU (1); DE (8); NZ (4); ES (2); GB (3); FR (7); IT (3); PL (2); BE (8)