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Drug Eluting Ballon Versus Stenting in the Superficial Femoral Artery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02212470
Recruitment Status : Active, not recruiting
First Posted : August 8, 2014
Last Update Posted : January 30, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Fabio H Rossi, Instituto Dante Pazzanese de Cardiologia

Brief Summary:
The purpose of this study is to evaluate whether the results of drug eluting balloon are equivalent to the Nitinol stent implantation in the Superficial Femoral Artery.

Condition or disease Intervention/treatment Phase
Superficial Femoral Artery Stenosis Device: Drug Eluting Balloon Angioplasty Device: Nitinol stenting Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral Artery
Actual Study Start Date : July 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Active Comparator: Drug Eluting Balloon
Admiral In.Pact Drug Eluting Balloon
Device: Drug Eluting Balloon Angioplasty
Angioplasty with Drug eluting balloon after pre dilatation
Other Names:
  • Medtronic
  • Admiral In.Pact

Active Comparator: Nitinol Stent
Complete SE Self-expandible Nitinol stent
Device: Nitinol stenting
Nitinol stent deployment
Other Names:
  • Medtronic
  • Complete SE




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212470


Locations
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Brazil
Instituto Dante Pazzanese de Cardiologia
Sao Paulo, Brazil, 04012909
Sponsors and Collaborators
Instituto Dante Pazzanese de Cardiologia
Medtronic
Investigators
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Principal Investigator: BRUNO L ALMEIDA, MD Instituto Dante Pazzanese de Cardiologia
Study Director: FABIO H ROSSI, MD, PHD Instituto Dante Pazzanese de Cardiologia

Publications:

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Responsible Party: Fabio H Rossi, MD, PHD, Instituto Dante Pazzanese de Cardiologia
ClinicalTrials.gov Identifier: NCT02212470     History of Changes
Other Study ID Numbers: IDPC_3 2014
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018