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Drug Eluting Stent for the Management of PERipheral Arterial Disease Of the SFA (DESPERADO-SFA Study) (DESPERADO)

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Balloon Angioplasty
Optical Coherence Tomography
Sponsored by
Arkansas Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with lower extremity claudication and Peripheral Arterial Disease (PAD) due to significant SFA stenosis (60%≤99%) or total occlusions (100%) that affects the quality of life despite medical therapy.

  • Evidence of significant SFA disease involving the most symptomatic limb by noninvasive vascular testing with the use of the following:

    • ABI: <0.9 (If ABI>1.4, SFA systolic acceleration time should be > 140 milliseconds);
    • TBI: <0.6;
    • Computed Tomographic Angiography (CTA) confirming at least a 60% SFA stenosis; or
    • Magnetic Resonance Angiography (MRA) confirming at least a 60% SFA stenosis
  • At least one patent, non-treated below the knee vessel.
  • Male and female patients that are ≥ 18 years of age.
  • Subject has been advised of the beneficial effects of smoking cessation and regular exercise but must not be in the process of changing their smoking status at the time of screening. Patients may resume or increase exercising as an effect of post procedurally improved lower limb perfusion.
  • Peak Walking Time (PWT) limited only by claudication.
  • Willingness to participate in the study, documented by signed, written informed consent.

Exclusion Criteria:

  • Planned usage of atherectomy devices during procedure. The following devices are the only permitted devices that can be used for intervention procedures:

    • Conventional balloons
    • Zilver PTXTM stent
  • Planned amputation.
  • Any planned/scheduled revascularization procedures ≤ 30 days after baseline procedure.
  • Prior lower extremity revascularization ≤ 30 days before baseline procedure.
  • The target lesion is an in-stent restenosis.
  • Infra-popliteal disease involving the last remaining vessel.
  • Patients with a creatinine clearance < 30mL/min.
  • Patients with known bleeding disorders.
  • Patients with known active pathological bleeding.
  • Patients with known hypersensitivity to acetylsalicylic acid, clopidogrel bisulfate, ticagrelor, Aspirin, or other antiplatelets/anticoagulants.
  • Patients with known history of intracranial hemorrhage at any time, GI bleed in the past 6 months, or major surgery within the past 30 days.
  • Patients with known ischemic stroke during the past 3 months.
  • Patients with known severe liver disease.
  • Patient with known history of congestive heart failure (CHF) with an LVEF of < 30%.
  • Patients considered being at risk of bradycardic events unless treated with a permanent pacemaker.
  • Female patients with known pregnancy, breast feeding, or intend to become pregnant during the study period (all female patients 55 years and younger, without a history of hysterectomy must have a pregnancy test prior to PPI at baseline and at 12 months).
  • Concern for inability of the patient to comply with study procedures and/or follow up (e.g., alcohol or drug abuse).

Sites / Locations

  • Arkansas Heart Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zilver PTX Stent

Arm Description

Diagnostic assessment of the lesion after implantation of drug eluting stent with Balloon Angioplasty and placement of the Zilver PTX Stent with Optical Coherence Tomography (OCT)

Outcomes

Primary Outcome Measures

Optimal Coherence Tomograpy
Identification of optimal stent apposition and expansion as well as identification of intraluminal clot at 12 month post procedure.

Secondary Outcome Measures

Full Information

First Posted
April 6, 2016
Last Updated
June 25, 2019
Sponsor
Arkansas Heart Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02734836
Brief Title
Drug Eluting Stent for the Management of PERipheral Arterial Disease Of the SFA (DESPERADO-SFA Study)
Acronym
DESPERADO
Official Title
Drug Eluting Stent for the Management of PERipheraal Arterial Disease of the SFA (DESPERADO-SFA Study)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
October 2, 2018 (Actual)
Study Completion Date
October 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arkansas Heart Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, nonrandomized, single-arm study using the Zilver PTXTM stent in patients with Superficial Femoral Artery (SFA) disease (total occlusions or significant stenosis).
Detailed Description
Endovascular therapy is widely used for the treatment of peripheral artery disease (PAD). Primary nitinol stenting for superficial femoral artery (SFA)) lesions has been shown to be superior to balloon angioplasty alone. Zilver PTX a paclitaxel -eluting nitinol stent has been approved by the Food and Drug Administration (FDA) for femoro-popliteal artery use. Previous study have reported safety and effectiveness of the Zilver PTZ in patients with de novo or re-stenotic lesions of the femoro-popliteal artery. Optical Coherence tomography (OCT) is a novel intravascular imaging modality with a unique and fine resolution of 10 µm at the level of a red blood cells providing detailed images of vascular wall following stent implantation for evaluation of optimal stent apposition and expansion as well as intraluminal clot. 20 patients with symptomatic critical limb ischemia (CLI) and claudication without CLI (Rutherford class 2-6) and identifiable SFA disease on angiogram requiring percutaneous peripheral intervention (PPI)will be enrolled in this study. We would like to study the vessel apposition and expansion immediately after initial implantation as well as evaluation of late stent malapposition and neointimal hyperplasia at the 12 months follow up after Zilver PTXTM stent implantation using intravascular OCT imaging. Follow up visits will take place at 1 month, 6 month, 12 month and 13 month after the procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zilver PTX Stent
Arm Type
Experimental
Arm Description
Diagnostic assessment of the lesion after implantation of drug eluting stent with Balloon Angioplasty and placement of the Zilver PTX Stent with Optical Coherence Tomography (OCT)
Intervention Type
Device
Intervention Name(s)
Balloon Angioplasty
Intervention Type
Other
Intervention Name(s)
Optical Coherence Tomography
Primary Outcome Measure Information:
Title
Optimal Coherence Tomograpy
Description
Identification of optimal stent apposition and expansion as well as identification of intraluminal clot at 12 month post procedure.
Time Frame
12 Month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with lower extremity claudication and Peripheral Arterial Disease (PAD) due to significant SFA stenosis (60%≤99%) or total occlusions (100%) that affects the quality of life despite medical therapy. Evidence of significant SFA disease involving the most symptomatic limb by noninvasive vascular testing with the use of the following: ABI: <0.9 (If ABI>1.4, SFA systolic acceleration time should be > 140 milliseconds); TBI: <0.6; Computed Tomographic Angiography (CTA) confirming at least a 60% SFA stenosis; or Magnetic Resonance Angiography (MRA) confirming at least a 60% SFA stenosis At least one patent, non-treated below the knee vessel. Male and female patients that are ≥ 18 years of age. Subject has been advised of the beneficial effects of smoking cessation and regular exercise but must not be in the process of changing their smoking status at the time of screening. Patients may resume or increase exercising as an effect of post procedurally improved lower limb perfusion. Peak Walking Time (PWT) limited only by claudication. Willingness to participate in the study, documented by signed, written informed consent. Exclusion Criteria: Planned usage of atherectomy devices during procedure. The following devices are the only permitted devices that can be used for intervention procedures: Conventional balloons Zilver PTXTM stent Planned amputation. Any planned/scheduled revascularization procedures ≤ 30 days after baseline procedure. Prior lower extremity revascularization ≤ 30 days before baseline procedure. The target lesion is an in-stent restenosis. Infra-popliteal disease involving the last remaining vessel. Patients with a creatinine clearance < 30mL/min. Patients with known bleeding disorders. Patients with known active pathological bleeding. Patients with known hypersensitivity to acetylsalicylic acid, clopidogrel bisulfate, ticagrelor, Aspirin, or other antiplatelets/anticoagulants. Patients with known history of intracranial hemorrhage at any time, GI bleed in the past 6 months, or major surgery within the past 30 days. Patients with known ischemic stroke during the past 3 months. Patients with known severe liver disease. Patient with known history of congestive heart failure (CHF) with an LVEF of < 30%. Patients considered being at risk of bradycardic events unless treated with a permanent pacemaker. Female patients with known pregnancy, breast feeding, or intend to become pregnant during the study period (all female patients 55 years and younger, without a history of hysterectomy must have a pregnancy test prior to PPI at baseline and at 12 months). Concern for inability of the patient to comply with study procedures and/or follow up (e.g., alcohol or drug abuse).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Cilingiroglu, MD
Organizational Affiliation
Arkansas Heart Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerardo Rodriguez, MD PhD
Organizational Affiliation
Arkansas Heart Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Arkansas Heart Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Drug Eluting Stent for the Management of PERipheral Arterial Disease Of the SFA (DESPERADO-SFA Study)

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