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

NCT02734836 | Completed

• 1 other identifier: AHH-2016-020
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Optimal Coherence Tomograpy

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

  12 Month

Study Arms (1)

Zilver PTX Stent

EXPERIMENTAL

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)

Device: Balloon Angioplasty; Other: Optical Coherence Tomography

Interventions

Balloon Angioplasty DEVICE

Zilver PTX Stent

Optical Coherence Tomography OTHER

Zilver PTX Stent

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arkansas Heart Hospital: lead

Study Sites (1)

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Angioplasty, Balloon; Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography

Study Officials

• Mehmet Cilingiroglu, MD

  Arkansas Heart Hospital

  PRINCIPAL INVESTIGATOR

• Gerardo Rodriguez, MD PhD

  Arkansas Heart Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 12, 2016
• Study Start: April 1, 2016
• Primary Completion: October 2, 2018
• Study Completion: October 2, 2018
• Last Updated: June 26, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)