Global Study of a Drug-coated Balloon to Treat Obstructive SFA and/or Popliteal Lesions

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01927068
First received: July 25, 2013
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

Single-Arm, multicenter study to continue to assess the safety and performance of the CVI Paclitaxel-Coated PTA Balloon Catheter in the treatment of de novo or restenotic lesions in the superficial femoral and/or popliteal arteries.


Condition Intervention
Peripheral Arterial Disease
Device: CVI Paclitaxel-Coated PTA Balloon Catheter

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: ILLUMENATE GLOBAL: Prospective, Single-Arm, Global Multi-Center Study to Evaluate Treatment of Obstructive Superficial Femoral Artery and/or Popliteal Lesions With a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • Primary Safety Endpoint [ Time Frame: Through 30 days post-procedure. ] [ Designated as safety issue: Yes ]
    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.

  • Primary Efficacy Endpoint [ Time Frame: 12 months post-procedure. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 500
Study Start Date: July 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CVI Paclitaxel-Coated PTA Balloon Catheter Device: CVI Paclitaxel-Coated PTA Balloon Catheter
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has clinically significant 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 2-3 subjects should be entered into the study if conservative treatment has been unsuccessful.
  3. Is at least 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.

Angiographic Inclusion Criteria

  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, 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 length of no more than 20 cm.
  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.
  6. Has a successful exchangeable guidewire crossing of the lesion(s).

Exclusion Criteria:

  1. Is pregnant, of childbearing potential not taking adequate contraceptive measures, or nursing.
  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 within 30 days of the index procedure.

Angiographic Exclusion Criteria

  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). Treatment of target lesion(s) is acceptable after successful treatment of inflow 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 aneurysmal target vessel.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01927068

Locations
Belgium
Onze Lieve Vrouw Ziekenhuis
Aalst, Belgium, 9300
Imelda Hospital
Bonheiden, Belgium, 2820
AZ Sint-Blasius
Dendermonde, Belgium, 9200
ZOL Campus Sint Jan
Genk, Belgium, 3600
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1023
Middlemore Hospital
Auckland, New Zealand, 2015
Waikato Hospital
Hamilton, New Zealand, 3240
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Thomas Zeller, MD Herz-Zentrum Bad Krozingen, Germany
Principal Investigator: Andrew Holden, MD Auckland Hospital, New Zealand
Principal Investigator: Yann Goueffic, MD Hopital Nord Laennec
Principal Investigator: Carlos Mena, MD Yale University
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01927068     History of Changes
Other Study ID Numbers: CP-1005, CP-1005
Study First Received: July 25, 2013
Last Updated: February 12, 2014
Health Authority: New Zealand: Medsafe
Australia: Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Italy: Ministry of Health
Netherlands: Dutch Health Care Inspectorate
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Switzerland: Swiss Agency for Therapeutic Products
Colombia: National Institute for the Surveillance of Drugs & Food

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014