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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02097082




Registration number
NCT02097082
Ethics application status
Date submitted
24/03/2014
Date registered
26/03/2014
Date last updated
6/09/2019

Titles & IDs
Public title
Treatment of SFA Lesions With 480 Biomedical STANZA™ Drug-Eluting Resorbable Scaffold (DRS) System
Scientific title
An Evaluation of the 480 Biomedical STANZA™ Drug-Eluting Resorbable Scaffold (DRS) System in the Treatment of de Novo SFA Lesions
Secondary ID [1] 0 0
480-SFA2013-001
Universal Trial Number (UTN)
Trial acronym
SPRINT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Intermittent Claudication 0 0
Vascular Diseases 0 0
Cardiovascular Diseases 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - STANZA Drug-eluting resorbable Scaffold

Experimental: STANZA Drug-eluting Resorbable Scaffold - Treatment of Superficial Femoral Artery (SFA) lesion with resorbable scaffold


Treatment: Devices: STANZA Drug-eluting resorbable Scaffold


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patency by Ultrasound - Patency measured by duplex ultrasound with =50% restenosis (Peak Systolic Velocity Ratio (PSVR = 2.4).
Timepoint [1] 0 0
through 6 months
Primary outcome [2] 0 0
Major Adverse Events - Freedom from all causes of death, emergent endovascular intervention or surgical intervention on the target limb, index limb amputation.
Timepoint [2] 0 0
30 days
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
48 hours
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Procedure
Secondary outcome [3] 0 0
Technical Success - Technical success is defined on a per lesion basis, as the achievement of a final residual stenosis of = 30%.
Timepoint [3] 0 0
Procedure
Secondary outcome [4] 0 0
Patency by Ultrasound - Patency measured by duplex ultrasound with =50% restenosis (PSVR = 2.4) based on core lab evaluation at 12 and 24 months.
Timepoint [4] 0 0
12, 24 months
Secondary outcome [5] 0 0
Patency by Angiography - =50% diameter stenosis determined by an angiographic core lab analysis of an angiogram performed at 12 months.
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
6,12, 24 months
Secondary outcome [7] 0 0
Surgical Intervention on the target limb, index limb amputation
Timepoint [7] 0 0
3,6,12, and 24 months

Eligibility
Key inclusion criteria
Inclusion Criteria

1. Age > 18 years.

2. 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.

3. 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.

4. 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.

5. The study patient agrees to comply with all required post-procedure study
requirements.

Baseline Inclusion Criteria

1. Reference vessel diameter (RVD) 5.0 -6.0 mm measured by an objective measurement such
as online Quantitative Vessel Analysis (QVA).

2. Target lesion length = 90 mm; total occlusion length < 40 mm.

3. Target lesion has a =70% diameter stenosis.

4. 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.

5. 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.

6. 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%.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria

1. Previous vascular surgery/endovascular treatment of the target lesion.

2. Re-vascularization of target vessel within 30 days of study procedure.

3. Critical limb ischemia defined as Rutherford Becker Category 4-6.

4. Known coagulation disorders or intolerance or allergies to aspirin, clopidogrel or
ticlopidine, heparin, any scaffold components, contrast agents which cannot be
adequately pre-medicated.

5. Life expectancy =12 months.

6. Planned procedure that necessitates the discontinuation of antiplatelet medications
used in conjunction with the investigational device within 3 months post-procedure.

7. Inability to walk due to orthopedic or other nonvascular complications.

8. Pregnancy or breast feeding or patient desires to become pregnant.

9. Non-atherosclerotic lesion (e.g. vasculitis).

10. Renal insufficiency (serum creatinine level > 220 µmol/L or > 2.5 mg/dl, or patient is
on dialysis).

11. Patient has medical condition(s) which could affect study assessments or may adversely
affect the safety and/or success of the study treatment.

12. Active systemic infection or lower limb infection of any nature.

13. White Blood Cells (WBC) = 3,000 cells/mm3.

14. Myocardial infarction within 30 days prior to the study procedure.

15. Stroke within 90 days prior to the study procedure.

16. Uncontrolled atrial fibrillation.

17. 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.

18. Prior use of paclitaxel-eluting products in the target limb less than 6 months prior
to index procedure.

19. Patient has known unstable angina.

Baseline Exclusion Criteria

1. Target lesion treatment with a drug eluting balloon.

2. Target lesion treatment with atherectomy, laser, or cryoplasty (use of a cutting or
scoring balloon is permitted prior to scaffold implantation only).

3. Suspicion for or evidence of subintimal passage of guidewire.

4. Severely calcified lesion(s).

5. Target lesion which, based on two angiographic orthogonal views, exhibit a persistent
balloon deformity during pre-dilatation with a nominally sized balloon.

6. Target vessel (superficial femoral artery) has an angiographically significant (> 50%
diameter stenosis) lesion located distally or proximally to the target lesion.

7. Acute embolic complication following pre-dilatation.

8. Target vessel contains an acute thrombus.

9. Aneurysm in target vessel or co-existing clinically significant aneurysmal disease of
the abdominal aorta, iliac or popliteal arteries.

10. Intervention in the infra-inguinal arteries outside of the target lesion.

11. Planned procedure within 30 days after the index procedure.

12. Positive pregnancy test for females of child bearing potential.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Germany
State/province [3] 0 0
Baden-Wuerttemberg
Country [4] 0 0
Germany
State/province [4] 0 0
Bavaria
Country [5] 0 0
Germany
State/province [5] 0 0
Saxony
Country [6] 0 0
New Zealand
State/province [6] 0 0
Auckland
Country [7] 0 0
Switzerland
State/province [7] 0 0
Bern
Country [8] 0 0
Switzerland
State/province [8] 0 0
Zurich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
480 Biomedical
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT02097082
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Holden, MD
Address 0 0
Auckland City Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications