PTA and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia (PADI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
H. van Overhagen MD PhD, Netherlands Society for Interventional Radiology
ClinicalTrials.gov Identifier:
NCT00471289
First received: May 7, 2007
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to investigate the performance of paclitaxel-coated balloon expandable stainless steel coronary stent for the treatment of infrapopliteal stenoses and occlusions in patients with critical limb ischemia compared to percutaneous transluminal balloon angioplasty (PTA).


Condition Intervention Phase
Peripheral Vascular Disease
Device: PTA with placement of paclitaxel-eluting stent
Device: PTA
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Percutaneous Transluminal Balloon Angioplasty (PTA) and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia

Resource links provided by NLM:


Further study details as provided by Netherlands Society for Interventional Radiology:

Primary Outcome Measures:
  • The primary endpoint will be primary patency of the treated site at 6 months. Primary patency is defined as <50% loss of luminal diameter at the treated site on CT arteriography (CTA) without re-intervention in the interim. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Primary patency of the treated sites at 3, 6 and 12 months after intervention assessed by duplex sonography (binary patency, <50% stenosis defined as PSV ratio <2.0) [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
  • Clinical evaluation of the treated ischemic leg at 3, 6 and 12 months. [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
  • Major amputation (at or above the ankle) of the trial leg at 3, 6 and 12 months [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
  • Minor amputation (below the ankle excluding the toes) of the trial leg at 3, 6 and 12 months. [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
  • Infrapopliteal surgical bypass of the trial leg at 3, 6 and 12 months. [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
  • Infrapopliteal endovascular re-intervention of the trial leg at 3, 6 and 12 months. [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
  • Peri-procedural (within 30 days) complications. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Death. [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
  • Clinical assessment primarily by Rutherford score for peripheral arterial disease [ Time Frame: 2, 3, 4 and 5 years after treatment ] [ Designated as safety issue: No ]
    Clinical assessment outpatient clinic

  • Target lesion patency by means of duplex sonography [ Time Frame: 2, 3, 4 and 5 years after treatment ] [ Designated as safety issue: No ]
    During outpatient clinic visits

  • Major amputation (at or above the ankle) of treated limb [ Time Frame: yearly up to 10 years after treatment ] [ Designated as safety issue: No ]
    Assessment up to 5 years after treatment during outpatient clinic visits From 5 to 10 years by means of yearly evaluation of patient charts

  • Minor amputation (below the ankle excluding the toes) of the trial leg at 3, 6 and 12 months. [ Time Frame: yearly up to 10 years after treatment ] [ Designated as safety issue: No ]
    From 2 to 5 years during outpatient clinic visits From 5 to 10 years yearly evaluation of patient charts

  • Endovascular or surgical re-intervention of target lesion [ Time Frame: 3, 6, 12 months, 2,3,4 and 5 years after inclusion ] [ Designated as safety issue: No ]
    Follow-up until first re-intervention of target lesion


Enrollment: 144
Study Start Date: August 2007
Estimated Study Completion Date: March 2023
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
PTA with primary placement of Drug (paclitaxel) Eluting Stent
Device: PTA with placement of paclitaxel-eluting stent
PTA with placement of paclitaxel-eluting stent
Active Comparator: 2
PTA
Device: PTA
PTA

Detailed Description:

Critical limb ischemia (CLI) is a serious condition that is becoming more and more common in the western world due to the growing percentage of elderly in the population and the rising incidence of diabetes. In about 40% of patients a stenosis or occlusion in the arteries below the level of the knee will be present. Restoration of blood flow is imperative to allow pain relief and tissue healing. Without revascularization patients with CLI are at risk for limb loss and potentially fatal complications such as sepsis.

In patients treated with percutaneous transluminal balloon angioplasty (PTA)significant restenosis is found in approximately 50% after 6 months.

In interventional cardiology a significant reduction in restenosis rates in coronary arteries has been found using drug eluting stents (DES), including the paclitaxel eluting stent (TAXUS, Boston Scientific). DES locally deliver drugs (e.g. paclitaxel) that interfere with the restenosis process.

Using DES in treating below the knee (infrapopliteal) arterial lesions in patients with CLI may improve patency and clinical outcome.

Comparison:

Treatment of below the knee arterial lesions in patients with CLI with PTA and DES compared to only PTA.

  Eligibility

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

Inclusion Criteria:

  • Written informed consent
  • Age > 18 years
  • If female patient with child bearing potential, patient may not be pregnant at the study entry and must utilize reliable birth control for the duration of her participation into the study
  • Patient is willing and able to comply with the specified follow-up evaluation
  • Critical Limb Ischaemia, this is Fontaine stage III (ischaemic rest pain) and IV (ischaemic ulcers or gangrene) or Rutherford category 4 (ischaemic rest pain), 5 (minor tissue loss) or 6 (major tissue loss)
  • Stenotic (>50% luminal loss) or occluded infrapopliteal artery, including the tibiofibular trunk, the anterior tibial artery, the posterior tibial artery and the peroneal artery, with a lesion length ≤ 60 mm
  • Artery to be treated with a diameter more tham or equal to 2mm and less than or equal to 4mm
  • Patent common iliac, external iliac, superficial femoral and popliteal artery on the ipsilateral side prior to randomisation, possibly after treatment during the same session
  • At least one patent crural (anterior tibial, posterior tibial or peroneal) artery with expected unobstructed runoff to ankle level after treatment

Exclusion Criteria:

  • Acute limb ischaemia
  • Subacute limb ischaemia which requires thrombolysis as first treatment modality
  • Active bleeding or bleeding diathesis
  • Recent (less than 3 months) hemorrhagic stroke or other any other CNS abnormality with increased risk of haemorrhage, such as intracranial neoplasm, arteriovenous malformation, intracranial aneurysm or aneurysm repair
  • Gastrointestinal or genitourinary bleeding of clinical significance within the previous 6 weeks before treatment
  • Aneurysm in common femoral, superficial femoral or popliteal artery on the ipsilateral side
  • Revascularization involving the same limb within 30 days prior to the index procedure or planned revascularization of the same limb within 30 days of the index procedure
  • Previous implanted stent at the index site
  • Life expectancy of less than 6 months or other factors making clinical follow-up difficult
  • Known allergy to acetylsalicylic acid (aspirin), clopidogrel, heparin or paclitaxel
  • Known allergy to contrast media
  • Known heparin induced thrombocytopenia (HIT type 2)
  • Patient unable or unwilling to tolerate anticoagulant, anti-platelet therapy or contrast media
  • Creatinine clearance < 20 ml/min (as derived from Cockcroft-Gault or MDRD formula)unless patient is on hemodialysis
  • Aneurysm in common femoral, superficial femoral or popliteal artery on the ipsilateral side
  • Severely calcified lesions with expected resistance to stenting
  • Poor inflow due to ipsilateral stenoses or occlusions of the iliac or femoropopliteal arteries that cannot be treated during the same session
  • Significant vessel tortuosity or other parameters prohibiting access to the lesions and/or delivery of the stent
  • Patients without (expected) distal runoff to the index site
  • Previous implanted stent at the index site
  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: NCT00471289

Locations
Netherlands
Sint Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands
HagaZiekenhuis, location Leyweg
The Hague, ZH, Netherlands, 2545CH
University Medical Center Utrecht (UMCU)
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
Netherlands Society for Interventional Radiology
Investigators
Principal Investigator: Hans Van Overhagen, MD PhD HagaZiekenhuis Dept. of Radiology
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: H. van Overhagen MD PhD, Radiologist Haga Teaching Hospital The Hague, Netherlands Society for Interventional Radiology
ClinicalTrials.gov Identifier: NCT00471289     History of Changes
Other Study ID Numbers: PADI/200601
Study First Received: May 7, 2007
Last Updated: May 23, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Netherlands Society for Interventional Radiology:
Critical Limb Ischemia
Stents
Drug Eluting Stents
Peripheral arterial disease
PAD
Paclitaxel
TAXUS
Infrapopliteal
Infragenicular
Interventional Radiology
CLI
DES

Additional relevant MeSH terms:
Ischemia
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive 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 01, 2014