Peripheral Arterial DiseaseSPRINTNCT02097082
Treatment of SFA Lesions With 480 Biomedical STANZA™ Drug-Eluting Resorbable Scaffold (DRS) System
A study testing STANZA Drug-eluting resorbable Scaffold in people with Peripheral Arterial Disease and Intermittent Claudication, run by 480 Biomedical at 9 sites in 4 countries.
Trial summary
An evaluation of the safety and performance of the STANZA Drug-eluting Resorbable Scaffold (DRS) system for the treatment of patients with obstructive superficial femoral artery disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease, Intermittent Claudication, Vascular Diseases
- What is being tested?
- STANZA Drug-eluting resorbable Scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 9 sitesin 4 countries
- Study dates
- Oct 2013to May 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years.
- De novo stenotic lesion(s) in the superficial femoral artery located at least 1 cm distal to the femoral bifurcation and > 5 cm above the joint space of the knee.
- Patient has symptomatic intermittent claudication affecting at least the target leg (Rutherford Class 2-3). Patients should have first received conservative medical management of their symptoms prior to study inclusion. The symptoms can be bilateral.
- The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the ethics committee of the respective clinical site.
- The study patient agrees to comply with all required post-procedure study requirements.
- Baseline Inclusion Criteria
Show all 12Show fewer
- Reference vessel diameter (RVD) 5.0 -6.0 mm measured by an objective measurement such as online Quantitative Vessel Analysis (QVA).
- Target lesion length ≤ 90 mm; total occlusion length < 40 mm.
- Target lesion has a ≥70% diameter stenosis.
- Angiographic evidence of at least one runoff vessel to the ankle/foot without hemodynamically significant stenosis (>50% diameter stenosis) that does not require any treatment within 3 months of the index procedure.
- Procedural access can be accomplished via contralateral vascular access or if antegrade access no closure device can be utilized and closure has to occur via manual pressure.
- Patent common and external iliac: TASC A \& B iliac lesions may be treated at the time of index procedure (before treatment of the target lesion) if residual stenosis is ≤30%.
Who cannot join
- Previous vascular surgery/endovascular treatment of the target lesion.
- Re-vascularization of target vessel within 30 days of study procedure.
- Critical limb ischemia defined as Rutherford Becker Category 4-6.
- Known coagulation disorders or intolerance or allergies to aspirin, clopidogrel or ticlopidine, heparin, any scaffold components, contrast agents which cannot be adequately pre-medicated.
- Life expectancy ≤12 months.
- Planned procedure that necessitates the discontinuation of antiplatelet medications used in conjunction with the investigational device within 3 months post-procedure.
Show all 32Show fewer
- Inability to walk due to orthopedic or other nonvascular complications.
- Pregnancy or breast feeding or patient desires to become pregnant.
- Non-atherosclerotic lesion (e.g. vasculitis).
- Renal insufficiency (serum creatinine level > 220 µmol/L or > 2.5 mg/dl, or patient is on dialysis).
- Patient has medical condition(s) which could affect study assessments or may adversely affect the safety and/or success of the study treatment.
- Active systemic infection or lower limb infection of any nature.
- White Blood Cells (WBC) ≤ 3,000 cells/mm3.
- Myocardial infarction within 30 days prior to the study procedure.
- Stroke within 90 days prior to the study procedure.
- Uncontrolled atrial fibrillation.
- Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
- Prior use of paclitaxel-eluting products in the target limb less than 6 months prior to index procedure.
- Patient has known unstable angina.
- Baseline Exclusion Criteria
- Target lesion treatment with a drug eluting balloon.
- Target lesion treatment with atherectomy, laser, or cryoplasty (use of a cutting or scoring balloon is permitted prior to scaffold implantation only).
- Suspicion for or evidence of subintimal passage of guidewire.
- Severely calcified lesion(s).
- Target lesion which, based on two angiographic orthogonal views, exhibit a persistent balloon deformity during pre-dilatation with a nominally sized balloon.
- Target vessel (superficial femoral artery) has an angiographically significant (> 50% diameter stenosis) lesion located distally or proximally to the target lesion.
- Acute embolic complication following pre-dilatation.
- Target vessel contains an acute thrombus.
- Aneurysm in target vessel or co-existing clinically significant aneurysmal disease of the abdominal aorta, iliac or popliteal arteries.
- Intervention in the infra-inguinal arteries outside of the target lesion.
- Planned procedure within 30 days after the index procedure.
- Positive pregnancy test for females of child bearing potential.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Austria3 sites
Universitäts Klinikum Graz
Graz
WGKK - Hanusch-Krankenhaus
Vienna, 1140
Cardiovascular and Interventional Radiology- AKH
Vienna
Germany3 sites
Universitäts-Herzzentrum Freiburg-Bad Krozingen GmbH
Bad Krozingen, Baden-Wurttemberg, 79189
Universitätsklinikum Leipzig AöR
Leipzig, Saxony, 04103
RoMed Klinikum Rosenheim
Rosenheim, Bavaria, 83022
Switzerland2 sites
INSELSPITAL, Universitätsspital Bern
Bern
University Hospital Zurich
Zurich, CH-8091
About this study
Official title: An Evaluation of the 480 Biomedical STANZA™ Drug-Eluting Resorbable Scaffold (DRS) System in the Treatment of de Novo SFA Lesions
An evaluation of the safety and performance of the STANZA Drug-eluting Resorbable Scaffold (DRS) system for the treatment of patients with obstructive superficial femoral artery disease.
Read the detailed description
The STANZA DRS system is comprised of a controlled release paclitaxel-eluting bioresorbable scaffold and a delivery system used in the treatment of superficial femoral artery disease.
- Conditions
- Peripheral Arterial Disease, Intermittent Claudication, Vascular Diseases, Cardiovascular Diseases
- Being tested
- STANZA Drug-eluting resorbable Scaffold
- Keywords
- Peripheral Arterial Disease, Intermittent Claudication, Vascular Diseases, Cardiovascular Diseases, Superficial Femoral Artery
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STANZA Drug-eluting resorbable ScaffoldDevice
Also called Paclitaxel-eluting resorbable scaffold
| Study group | Role | What they receive |
|---|---|---|
| STANZA Drug-eluting Resorbable Scaffold | Experimental | Treatment of Superficial Femoral Artery (SFA) lesion with resorbable scaffold Receives: Device: STANZA Drug-eluting resorbable Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency by Ultrasound
Patency measured by duplex ultrasound with ≤50% restenosis (Peak Systolic Velocity Ratio (PSVR ≤ 2.4).
Measured: through 6 months
Major Adverse Events
Freedom from all causes of death, emergent endovascular intervention or surgical intervention on the target limb, index limb amputation.
Measured: 30 days
Secondary outcomes (7)
Clinical Success
On a per patient basis, technical success without major adverse event (MAE) within 48 hours after the index procedure or at hospital discharge, whichever is sooner.
Measured: 48 hours
Device Success
On a per device basis, the achievement of successful delivery and deployment of the study device at the intended target lesion and successful withdrawal of the delivery catheter.
Measured: Procedure
Technical Success
Technical success is defined on a per lesion basis, as the achievement of a final residual stenosis of ≤ 30%.
Measured: Procedure
Patency by Ultrasound
Patency measured by duplex ultrasound with ≤50% restenosis (PSVR ≤ 2.4) based on core lab evaluation at 12 and 24 months.
Measured: 12, 24 months
Patency by Angiography
≤50% diameter stenosis determined by an angiographic core lab analysis of an angiogram performed at 12 months.
Measured: 12 months
Clinically Driven Target Lesion Revascularization (TLR)
Clinically Driven TLR is defined as symptomatic patients with:
Decrease in Ankle Brachial Index (ABI) > 0.15 and Increase in Rutherford Becker Category ≥ 1 from post procedure assessment and >50% stenosis by angiography.
Measured: 6,12, 24 months
Surgical Intervention on the target limb, index limb amputation
Measured: 3,6,12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startOct 2013
- Primary completion30 Mar 2016
- Study completionMay 2017
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- 480 Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Holden, MD, Principal investigator, Auckland City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097082
- Sponsor's protocol ID
- 480-SFA2013-001
- Acronym
- SPRINT
- Status last verified
- Sep 2019
- First submitted
- 24 Mar 2014
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the 480 Biomedical STANZA™ Drug-Eluting Resorbable Scaffold (DRS) System in the Treatment of de Novo SFA Lesions
- ClinicalTrials.gov ID
- NCT02097082
- Acronym / sponsor ID
- SPRINT / 480-SFA2013-001
- Conditions
- Peripheral Arterial Disease, Intermittent Claudication, Vascular Diseases, Cardiovascular Diseases
- Keywords
- Peripheral Arterial Disease, Intermittent Claudication, Vascular Diseases, Cardiovascular Diseases, Superficial Femoral Artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- 480 BiomedicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- 30 Mar 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 26 Mar 2014 (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.
An evaluation of the safety and performance of the STANZA Drug-eluting Resorbable Scaffold (DRS) system for the treatment of patients with obstructive superficial femoral artery disease.
Detailed description
The STANZA DRS system is comprised of a controlled release paclitaxel-eluting bioresorbable scaffold and a delivery system used in the treatment of superficial femoral artery disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STANZA Drug-eluting Resorbable Scaffold | Experimental | Device: STANZA Drug-eluting resorbable ScaffoldTreatment of Superficial Femoral Artery (SFA) lesion with resorbable scaffold |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age > 18 years.
- De novo stenotic lesion(s) in the superficial femoral artery located at least 1 cm distal to the femoral bifurcation and > 5 cm above the joint space of the knee.
- Patient has symptomatic intermittent claudication affecting at least the target leg (Rutherford Class 2-3). Patients should have first received conservative medical management of their symptoms prior to study inclusion. The symptoms can be bilateral.
- The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the ethics committee of the respective clinical site.
- The study patient agrees to comply with all required post-procedure study requirements.
Key exclusion criteria (32 listed)
- Previous vascular surgery/endovascular treatment of the target lesion.
- Re-vascularization of target vessel within 30 days of study procedure.
- Critical limb ischemia defined as Rutherford Becker Category 4-6.
- Known coagulation disorders or intolerance or allergies to aspirin, clopidogrel or ticlopidine, heparin, any scaffold components, contrast agents which cannot be adequately pre-medicated.
- Life expectancy ≤12 months.
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 |
|---|---|---|
| STANZA Drug-eluting resorbable ScaffoldAlso: Paclitaxel-eluting resorbable scaffold | Device | STANZA Drug-eluting Resorbable Scaffold |
Primary outcome
Patency by Ultrasound
Time frame: through 6 months
Patency measured by duplex ultrasound with ≤50% restenosis (Peak Systolic Velocity Ratio (PSVR ≤ 2.4).
Major Adverse Events
Time frame: 30 days
Freedom from all causes of death, emergent endovascular intervention or surgical intervention on the target limb, index limb amputation.
7 secondary outcomes
Clinical Success
Time frame: 48 hours
Device Success
Time frame: Procedure
Technical Success
Time frame: Procedure
Patency by Ultrasound
Time frame: 12, 24 months
Patency by Angiography
Time frame: 12 months
Clinically Driven Target Lesion Revascularization (TLR)
Time frame: 6,12, 24 months
Surgical Intervention on the target limb, index limb amputation
Time frame: 3,6,12, and 24 months
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 6 Sep 2019.
Related trials for Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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.
Andrew Holden, MD principal investigator
Auckland City Hospital
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STANZA Drug-eluting resorbable Scaffold in people with Peripheral Arterial Disease and Intermittent Claudication, run by 480 Biomedical at 9 sites in 4 countries.
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 12 inclusion and 32 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 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Austria, Germany, Switzerland, New Zealand. 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?
Patency by Ultrasound (time frame: through 6 months). The study lists 2 primary outcomes in all. 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 6 Sep 2019.