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

NCT ID: NCT01927068

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 499 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2022-08-31

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.

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Global Cohort 1

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

ISR Cohort 2

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DEVICE

Other Intervention Names

CVI Paclitaxel-Coated PTA Balloon Catheter

Eligibility Criteria

Inclusion Criteria

1. Has symptomatic leg ischemia, requiring treatment of the SFA and/or popliteal artery.

2. 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.

3. Is ≥18 years old.

4. Has life expectancy >1 year.

5. Is able and willing to provide written informed consent prior to study specific procedures.

6. Is willing and capable of complying with the required follow-up visits, testing schedule and medication regimen.

1. 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.

2. 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.

3. 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.

4. Has target lesion(s) located >2 cm from any stent if the target vessel was previously stented.

5. Has a reference vessel diameter of 4 - 6 mm by visual estimate.

6. Has a successful exchangeable guidewire crossing of the lesion(s).

1. Has symptomatic leg ischemia, requiring treatment of the SFA and/or popliteal artery.

2. 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.

3. Is between 18-85 years old.

4. Has life expectancy >1 year.

5. Is able and willing to provide written informed consent prior to study specific procedures.

6. Is willing and capable of complying with the required follow-up visits, testing schedule and medication regimen.

7. History of previous femoropopliteal nitinol stenting which is suspect for in-stent restenosis.

8. The patient has a resting ankle-brachial index (ABI) <0.9 or an abnormal exercise ABI (<0.9) if resting ABI is normal. Patient with incompressible arteries (ABI>1.2) must have a toe-brachial index (TBI) <0.7 in target limb.

1. Has angiographic evidence of significant restenosis (≥50% by visual estimate) within a previously deployed femoropopliteal bare nitinol stent(s) including ISR Class I, II or III.

2. 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.

3. Total target treatment length of in-stent restenosis must be ≥4.0 cm in length and may include a single lesion or a multifocal lesion within the femoropopliteal segment (This includes the proximal, mid, and/or distal SFA and PI, P2 and/or P3 segment of the popliteal artery). Edge restenosis may be treated provided the lesion extends no more than 3 cm outside the margin of the stent (proximal and/or distal margin).

4. Has target lesion(s) located >2 cm from any stent if the target vessel was previously stented.

5. Has a reference vessel diameter of 4 - 6 mm by visual estimate.

6. Has a successful exchangeable guidewire crossing of the lesion(s).

Exclusion Criteria

1. 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.

2. Has significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy

3. Has known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.

4. Is currently participating in another investigational device or drug study that would interfere with study endpoints.

5. Has history of hemorrhagic stroke within 3 months.

6. Has surgical or endovascular procedure of the target limb within 14 days prior to the index procedure.

7. Has any planned surgical intervention (requiring hospitalization) or endovascular procedure within 30 days after the index procedure.

8. Has had a previous peripheral bypass affecting the target limb.

9. 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.

1. 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).

2. Has an acute or sub-acute intraluminal thrombus within the target vessel.

3. Has in-stent restenosis or restenosis of the target lesion following previous treatment with a drug-coated balloon.

4. Has an aneurysm (at least twice the reference vessel diameter) located in the target vessel, abdominal aorta, iliac, or popliteal arteries.

5. Has perforation, dissection or other injury of the access or target vessel requiring stenting or surgical intervention prior to enrollment.

6. Has no normal arterial segment proximal to the target lesion in which duplex ultrasound velocity ratios can be measured.

7. Requires use of adjunctive therapies (i.e., laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy).

8. Has severe calcification that precludes adequate PTA treatment.

1. 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.

2. Has significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.

3. Has known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.

4. Is currently participating in another investigational device or drug study that would interfere with study endpoints.

5. Has history of hemorrhagic stroke within 3 months including those within <60 days with an unresolved walking impairment.

6. Has surgical or endovascular procedure of the target limb within 3 months prior to the index procedure.

7. Has any planned surgical intervention (requiring hospitalization) or endovascular procedure within 30 days after the index procedure.

8. Has had a previous peripheral bypass affecting the target limb.

9. Has unstable angina pectoris, myocardial infarction within 60 days, liver failure, renal failure or chronic kidney disease (dialysis dependent, or serum creatinine ≥2.5 mg/dL) within 30 days of the index procedure.

10. History of previous femoropopliteal stenting in the target lesion with drug eluting stents or covered stents (endografts).

1. Ipsilateral and/or contralateral iliac (or common femoral) artery stenosis

≥50% diameter stenosis (DS) that is not successfully treated prior to index procedure (e.g. where a perforation occurred requiring a covered stent) or with final residual stenosis ≥ 30% documented by angiography.

2. Identification of any lesion of the native vessel (excludes ISR) above the target stent in the femoropopliteal segment >50% that is not successfully treated prior to index procedure (e.g. complication requiring additional treatment) or with final residual stenosis >30% documented by angiography. Drug eluting stent (DES) and drug coated balloon (DCB) will not be allowed. The lesion length must be treatable with a single stent (if required). The lesion must not be contiguous with the target lesion; at least 2 cm of normal appearing vessel between the lesion and target lesion/ target stent or between deployed stent (if required) and the target lesion/ target stent.

3. Has an acute or sub-acute intraluminal thrombus within the target vessel.

4. Has an aneurysm (at least twice the reference vessel diameter) located in the target vessel, abdominal aorta, iliac, or popliteal arteries.

5. Has perforation, dissection or other injury of the access or target vessel requiring stenting or surgical intervention prior to enrollment.

6. Has no normal arterial segment proximal to the target lesion in which duplex ultrasound velocity ratios can be measured.

7. Requires use of adjunctive therapies (i.e., laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy).

8. Grade 4 or 5 stent fracture affecting target stent or proximal to the target stent, or where evidence of stent protrusion into the lumen is noted on angiography in 2 orthogonal views.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spectranetics Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Zeller, MBChB, FRANZCR

Role: PRINCIPAL_INVESTIGATOR

Herz-Zentrum Bad Krozingen, Germany

Andrew Holden, MD

Role: PRINCIPAL_INVESTIGATOR

Auckland Hospital, New Zealand

Yann Goueffic, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Nord Laennec, France

Locations

The Wesley St. Andrew Research Institute Ltd.

Auchenflower, , Australia

Flinders Medical Centre

Bedford, , Australia

Royal Brisbane and Women's Hospital

Brisbane, , Australia

Monash Medical Centre at Dandenong Campus

Dandenong, , Australia

The Alfred Hospital

Melbourne, , Australia

Sir Charles Gairdner Hospital

Nedlands, , Australia

Medizinische Universität Graz - Univ. Klinik für Innere Medizin

Graz, , Austria

Onze Lieve Vrouw Ziekenhuis

Aalst, , Belgium

Middelheim Hospital

Antwerp, , Belgium

Imelda Hospital

Bonheiden, , Belgium

AZ Sint-Blasius

Dendermonde, , Belgium

ZOL Campus Sint Jan

Genk, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

University Clinic Leuven

Leuven, , Belgium

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

Tienen, , Belgium

CHU de Clermont-Ferrand, Hôpital Gabriel Montpied

Clermont-Ferrand, , France

CHU de Lyon, Hôpital Edouard Herriot

Lyon, , France

Hopital de Ia Timone

Marseille, , France

CHU de Nantes, Hôpital Nord Laennec

Nantes, , France

Hôpital Européen georges Pompidou

Paris, , France

CHU de Rennes, Hôpital Pontchaillou

Rennes, , France

Clinique Pasteur

Toulouse, , France

Universitats-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, , Germany

Jüdisches Krankenhaus Berlin

Berlin, , Germany

Medizinische Universitätsklinik III

Heidelberg, , Germany

Klinikum Immenstadt, Herz-und Gefässzentrum Oberallgäu-Kempten

Immenstadt im Allgäu, , Germany

SRH Klinikum Karlsbad-Langensteinbach

Langensteinbach, , Germany

University Leipzig Medical Center

Leipzig, , Germany

RoMed Klinikum Rosenheim

Rosenheim, , Germany

Universitatsklinik, Abteilung Für Diagnostische und Inverventionelle Radiologie

Tübingen, , Germany

Ospedali Riuniti - SOD

Ancona, , Italy

Villa Maria Eleonora Hospital

Palermo, , Italy

S.C. Chirurgia Vascolare ed Endovascolare

Perugia, , Italy

Auckland City Hospital

Auckland, , New Zealand

Middlemore Hospital

Auckland, , New Zealand

Waikato Hospital

Hamilton, , New Zealand

Wellington Hospital

Wellington, , New Zealand

Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Instytut Hematologii i Transfuzjologii

Warsaw, , Poland

Centre d'Atencio Integral Hospital Dos de Maig

Barcelona, , Spain

Hospital Universitario Quirón de Madrid

Madrid, , Spain

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

London, , United Kingdom

King's College

London, , United Kingdom

UCL Division of Surgery and Interventional Science

London, , United Kingdom

Countries

Australia; Austria; Belgium; France; Germany; Italy; New Zealand; Poland; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 31567024 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CP-1005B

Identifier Type: OTHER

Identifier Source: secondary_id

CP-1005

Identifier Type: -

Identifier Source: org_study_id