Clinical trial NCT02212470: Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral Artery
Official title: Randomized Controlled Trial of Paclitaxel Drug-coated Balloons vs. Nitinol Stent for Femoropopliteal Obstructions - The PAVENST Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Arterial Disease
Arterial Occlusive Diseases
Atherosclerosis
Arteriosclerosis
Cardiovascular Diseases
Peripheral Vascular Diseases
Paclitaxel
Plaque, Atherosclerotic
Critical Limb Ischemia
Keywords: Artery
Atherosclerosis
Peripheral
Arterial
Plaque
PTA
Angioplasty
Femoropopliteal
Self Expandable Nitinol Stents
Lead sponsor: Instituto Dante Pazzanese de Cardiologia
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2014-08-08
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, single-center, single-blind, non-inferiority, clinical trial
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years with critical lower limb ischemia,
* Ruhtherford 3 or higher,
* with angiographic documentation of greater than 70% or occlusion in the superficial femoral artery,
* with a maximum extension of 10 cm stenosis.
* The popliteal artery and at least one leg artery must be patent.

Exclusion Criteria:

* Pregnancy,
* thrombophilia,
* coagulation disorders,
* presence of active or recent bleeding,
* severe allergy to iodinated contrast,
* renal or hepatic disease,
* acute limb ischemia,
* prior surgical bypass or angioplasty (with or without stent) on the target artery,
* obstructive disease (stenosis\> 50%) of the aortoiliac segment ipsilateral to the target (if the aortoiliac is pre-treated, the patient may be included)

Primary outcomes:
measure: Primary patency
timeFrame: 12 months
Secondary outcomes:
measure: Rutherford classification
timeFrame: 12 months
measure: Ankle braquial Index
timeFrame: 12 months
measure: Target Lesion Revascularization
timeFrame: 12 months
measure: Stent fracture
timeFrame: 12 months
measure: Amputation
timeFrame: 12 months
measure: Acute myocardial infarct
timeFrame: 12 months
measure: Death
timeFrame: 12 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
Study officials:
affiliation: Instituto Dante Pazzanese de Cardiologia
name: BRUNO L ALMEIDA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Dante Pazzanese de Cardiologia
name: FABIO H ROSSI, MD, PHD
role: STUDY_DIRECTOR
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