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

Netherlands Society for Interventional Radiology

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Peripheral Vascular Disease

Treatments

Device: PTA with placement of paclitaxel-eluting stent

Device: PTA

Study type

Interventional

Funder types

Other

Identifiers

NCT00471289

PADI/200601

Details and patient eligibility

About

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).

Full 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.

Enrollment

144 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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