Peripheral Arterial DiseaseDESPERADONCT02734836
Drug Eluting Stent for the Management of PERipheral Arterial Disease Of the SFA (DESPERADO-SFA Study)
A study testing Balloon Angioplasty and Optical Coherence Tomography in people with Peripheral Arterial Disease, run by Arkansas Heart Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Balloon Angioplasty and Optical Coherence Tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 2 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
About this study
Official title: Drug Eluting Stent for the Management of PERipheraal Arterial Disease of the SFA (DESPERADO-SFA Study)
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).
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Balloon Angioplasty, Optical Coherence Tomography
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon AngioplastyDevice
Optical Coherence TomographyOther
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Balloon Angioplasty; Other: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal Coherence Tomograpy
Identification of optimal stent apposition and expansion as well as identification of intraluminal clot at 12 month post procedure.
Measured: 12 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion2 Oct 2018
- Study completion2 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehmet Cilingiroglu, MD, Principal investigator, Arkansas Heart HospitalGerardo Rodriguez, MD PhD, Study director, Arkansas Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734836
- Sponsor's protocol ID
- AHH-2016-020
- Acronym
- DESPERADO
- Status last verified
- Jun 2019
- First submitted
- 6 Apr 2016
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Eluting Stent for the Management of PERipheraal Arterial Disease of the SFA (DESPERADO-SFA Study)
- ClinicalTrials.gov ID
- NCT02734836
- Acronym / sponsor ID
- DESPERADO / AHH-2016-020
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Arkansas Heart HospitalUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 2 Oct 2018 (actual)
- Study completion
- 2 Oct 2018 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zilver PTX Stent | Experimental | Device: Balloon Angioplasty, Other: Optical Coherence TomographyDiagnostic 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) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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.
Key exclusion criteria (19 listed)
- Planned usage of atherectomy devices during procedure. The following devices are the only permitted devices that can be used for intervention procedures:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balloon Angioplasty | Device | Zilver PTX Stent |
| Optical Coherence Tomography | Other | Zilver PTX Stent |
Primary outcome
Optimal Coherence Tomograpy
Time frame: 12 Month
Identification of optimal stent apposition and expansion as well as identification of intraluminal clot at 12 month post procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Cilingiroglu, MD principal investigator
Arkansas Heart Hospital
Gerardo Rodriguez, MD PhD study director
Arkansas Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon Angioplasty and Optical Coherence Tomography in people with Peripheral Arterial Disease, run by Arkansas Heart Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal Coherence Tomograpy (time frame: 12 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019.