Clinical trial NCT02097082: Treatment of SFA Lesions With 480 Biomedical STANZA™ Drug-Eluting Resorbable Scaffold (DRS) System
Official title: An Evaluation of the 480 Biomedical STANZA™ Drug-Eluting Resorbable Scaffold (DRS) System in the Treatment of de Novo SFA Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Intermittent Claudication
Vascular Diseases
Cardiovascular Diseases
Keywords: Peripheral Arterial Disease
Intermittent Claudication
Vascular Diseases
Cardiovascular Diseases
Superficial Femoral Artery
Lead sponsor: Lyra Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-03-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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%.

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.

Primary outcomes:
measure: Patency by Ultrasound
timeFrame: through 6 months
measure: Major Adverse Events
timeFrame: 30 days
Secondary outcomes:
measure: Clinical Success
timeFrame: 48 hours
measure: Device Success
timeFrame: Procedure
measure: Technical Success
timeFrame: Procedure
measure: Patency by Ultrasound
timeFrame: 12, 24 months
measure: Patency by Angiography
timeFrame: 12 months
measure: Clinically Driven Target Lesion Revascularization (TLR)
timeFrame: 6,12, 24 months
measure: Surgical Intervention on the target limb, index limb amputation
timeFrame: 3,6,12, and 24 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitäts Klinikum Graz
city: Vienna
country: Austria
facility: WGKK - Hanusch-Krankenhaus
city: Vienna
country: Austria
facility: Cardiovascular and Interventional Radiology- AKH
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg-Bad Krozingen GmbH
state: Baden-Wuerttemberg
city: Rosenheim
country: Germany
facility: RoMed Klinikum Rosenheim
state: Bavaria
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AöR
state: Saxony
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Bern
country: Switzerland
facility: INSELSPITAL, Universitätsspital Bern
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: Auckland City Hospital
name: Andrew Holden, MD
role: PRINCIPAL_INVESTIGATOR
References: