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Completed

NCT Number: NCT02212470

Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral Artery

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Critical Limb Ischemia Disease Attributes Ischemia Paclitaxel Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Plaque, Amyloid Plaque, Atherosclerotic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto Dante Pazzanese de Cardiologia

São Paulo, 04012909, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Drug Eluting Balloon Angioplasty

Device

Angioplasty with Drug eluting balloon after pre dilatation

Other names: Medtronic, Admiral In.Pact

Nitinol stenting

Device

Nitinol stent deployment

Other names: Medtronic, Complete SE

Primary outcomes

  1. Primary patency

    Time frame: 12 months

    Evaluations will be conducted after 3, 6 and 12 months of the procedure. The ultrasonographic evaluation of the degree of stenosis will use the Systolic Velocity Index (division of the velocity of flow at the point of greatest stenosis by the velocity of flow in normal prior segment). Rates higher than 2.4 indicate stenosis greater than 50%

Secondary outcomes

  1. Rutherford classification

    Time frame: 12 months

    Change in classification from Rutherford evaluated in 3, 6 and 12 months.

  2. Ankle braquial Index

    Time frame: 12 months

    Change in the Ankle braquial Index evaluated in 3, 6 and 12 months

  3. Target Lesion Revascularization

    Time frame: 12 months

    Target Lesion Revascularization rate evaluated in 3, 6 and 12 months

  4. Stent fracture

    Time frame: 12 months

    Stent fracture rate evaluated in 3, 6 and 12 months

  5. Amputation

    Time frame: 12 months

    Major amputation defined as amputation that requires prosthesis

  6. Acute myocardial infarct

    Time frame: 12 months

    Acute myocardial infarct rate evaluated in 3, 6 and 12 months

  7. Death

    Time frame: 12 months

    Death rate evaluated in 3, 6 and 12 months

Sponsors and collaborators

Lead sponsor

Instituto Dante Pazzanese de Cardiologia

Other

Collaborators

  • Medtronic

Registry information

Official study title

Randomized Controlled Trial of Paclitaxel Drug-coated Balloons vs. Nitinol Stent for Femoropopliteal Obstructions - The PAVENST Trial

Acronym: PAVENST

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Aug 8, 2014
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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