Primary objective: To demonstrate a superior patency rate and acceptable safety rates in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs percutaneous transluminal angioplasty. (PTA). Secondary objective: To…
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Effectiveness Endpoint (Phase A RCT)
The primary effectiveness endpoint assesses primary patency at 12 months
post-procedure. This effectiveness endpoint is designed to demonstrate that the
12-month primary patency for the DES BTK treatment group is superior to the PTA
treatment group at an overall one-sided significance level of 2.5%.
Primary vessel patency is defined as a binary endpoint to be determined via
duplex ultrasound (DUS) measuring flow or no flow at the 12-month follow-up
visit in the absence of clinically-driven target lesion revascularization (TLR)
or bypass of the target lesion. All DUS readings will be assessed by an
independent core laboratory.
Primary Safety Endpoint (Phase A RCT)
The primary safety endpoint assesses major adverse events (MAE) at 12 months
post-procedure. This safety endpoint is designed to demonstrate that the
12-month MAE-free rate for the DES BTK treatment group is non-inferior to the
PTA treatment group at an overall one-sided significance level of 2.5%.
A major adverse event is defined as the composite of:
• Above ankle amputation of the index limb
• Major re-intervention (ie, new bypass graft, jump/interposition graft, or
thrombectomy/thrombolysis)
• Perioperative (30 day) mortality
Secondary outcome
Additional Endpoints Phase A:
• Primary and assisted-primary patency at 1, 6, 12, 24, and 36 months
post-procedure
• Clinically-driven target lesion revascularization (TLR) rate at each time
point
• Hemodynamic outcomes (changes in Ankle-Brachial Index [ABI] and/or
Toe-Brachial Index [TBI]) at 6 and 12 months post procedure
• Wound assessment (changes in wound characteristics)
• Major amputation rate
• Change in Rutherford classification at 3, 6, 12, 24, and 36 months post
procedure
• Quality of Life (QOL) changes at 1, 3, 6 and 12 months post procedure
• Adverse events (AEs) at each time point (to be classified as major, serious,
non-serious, unanticipated, procedure-related and device-related)
• 30-day unplanned hospital readmission rate
Background summary
Critical limb ischemia is a debilitating disease, associated with poor clinical
outcomes, a high rate of amputations, and overall decreased quality of life.
Based on the significant clinical complications associated with bypass surgery,
the presence of chronic total occlusions, the restenotic characteristics with
PTA therapies, and the limitations of using coronary stents in BTK indications,
the need for an alternative therapy exists.
The DES BTK Vascular Stent System aims to address these treatment gaps and
clinical outcomes not adequately addressed by surgical bypass and/or PTA. The
DES BTK Vascular Stent System was designed for the unique considerations of
infrapopliteal disease, including long, tortuous lesions and the need for a
mechanism of providing an anti-proliferative agent to calcified vessels. The
DES BTK Vascular Stent System incorporates existing successful peripheral
drug-eluting stent technology to treat a similar disease state below the knee.
Study objective
Primary objective: To demonstrate a superior patency rate and acceptable safety
rates in below the knee arteries with lesions treated with the DES BTK Vascular
Stent System vs percutaneous transluminal angioplasty. (PTA).
Secondary objective: To collect additional information on limb salvage and
overall quality of life in this patient population.
Study design
The trial will be conducted in 1 phase.
Phase A is a global, pivotal, prospective, multicenter, 2:1 randomized
controlled trial (RCT) evaluating the safety and effectiveness of the DES BTK
Vascular Stent System compared to PTA for the treatment of lesions located in
the arteries below the knee in subjects with CLI.
Intervention
Test device : The DES BTK Vascular Stent System for treatment of lesions in the
infrapopliteal arteries.
Control device: Percutaneous Transluminal Angioplasty (PTA) balloon catheter.
For additional information please refer to the protocol (synopsis, page 18)
Study burden and risks
Subjects have to attend visits (screening, implantation of stent/PTA, follow up
visits) and a variety
of tests will be done to check their health. These include medicine use/
medical history and physical assessment, blood tests, questionnaires, pregnancy
testing, angiogram, x-ray of limb, ultrasound tests, ABI and TBI, wound
assessment & image. Subjects must use a birth
control method.
Risks include: Allergic reaction (to drug/polymer, contrast, device or other),
Amputation Bleeding/Hemorrhage, Death, Embolization (air, plaque, thrombus,
device, tissue or other), Hematoma, Ischemia, Need for urgent intervention or
surgery, Pseudoaneurysm formation, Renal insufficiency or failure, Restenosis
of stented artery, Sepsis/infection, Thrombosis / Thrombus, Transient
hemodynamic instability (hypotensive/hypertensive episodes), Vasospasm, Vessel
injury, including perforation, trauma, rupture and dissection, Vessel occlusion.
There are also risks associated with the Paclitaxel drug coating on the DES BTK
stent: Allergic/immunologic reactions to drug (paclitaxel or
structurally-related compounds) or the polymer stent coating (or its individual
components), Alopecia, Anemia, Gastrointestinal symptoms, Hematologic
dyscrasia (including leukopenia, neutropenia, and thrombocytopenia), Hepatic
enzyme changes, Histologic changes in the vessel wall, including inflammation,
cellular damage or necrosis, Myalgia/arthralgia, Peripheral neuropathy.
SOC antiplatelet medications is associated with the risk of bleeding. In
general there are risks associated with the blood draws and X-ray and potential
harm to the unborn child.
Critical limb ischemia is a debilitating disease, associated with poor clinical
outcomes, a high rate of amputations, and overall decreased quality of life.
Based on the significant clinical complications associated with bypass surgery,
the presence of chronic total occlusions, the restenotic characteristics with
PTA therapies, and the limitations of using coronary stents in BTK indications,
the need for an alternative therapy exists.
The DES BTK Vascular Stent System aims to address these treatment gaps and
clinical outcomes not adequately addressed by surgical bypass and/or PTA. The
DES BTK was designed for the unique considerations of infrapopliteal disease,
including long, tortuous lesions and the need for a mechanism of providing an
anti-proliferative agent to calcified vessels. The DES BTK incorporates
existing successful peripheral drug-eluting stent technology to treat a similar
disease state below the knee.
Boston Scientific Way 300
Marlborough MA 01752
US
Boston Scientific Way 300
Marlborough MA 01752
US
Listed location countries
Age
Inclusion criteria
Pre-procedure Inclusion Criteria
1. Subject is 18 years or older and has signed and dated the trial informed
consent form (ICF). Note: For subjects in Japan who are less than 20 years of
age, the subject*s legal representative must provide written informed consent
in addition to the subject
2. Subject is willing and able to comply with the trial testing, procedures and
follow-up schedule
3. Subject has chronic, symptomatic lower limb ischemia, determined by
Rutherford categories 4 or 5 in the target limb, with wound(s) confined to
toes/forefoot
4. Subject is a male or non-pregnant female. If female of child-bearing
potential, and if sexually active must be using, or agree to use, a medically-
acceptable method of birth control as confirmed by the investigator
Intra-Procedure Inclusion Criteria
1. Stenotic, restenotic or occlusive target lesion(s) located in the
tibioperoneal trunk, anterior tibial, posterior tibial and/or peroneal
artery(ies).
• Target lesion(s) must be at least 4cm above the ankle joint
• A single target lesion per vessel, in up to 2 vessels, in a single limb
• Degree of stenosis >= 70% by visual angiographic assessment
• Reference vessel diameter (RVD) is between 2.5 - 3.25mm for phase A RCT
• Total target lesion length (or series of lesion segments) to be treated is <=
140mm for phase A RCT after DMC approval for stent overlap (Note: Lesion
segment(s) must be fully covered with up to two DES BTK stents, if randomized
to stent)
• Total target lesion length (or series of lesion segments) to be treated is <=
140mm for phase B non-randomized (Note: Lesion segment(s) must be fully covered
with up to two DES BTK stents)
2. Target vessel(s) reconstitute(s) at or above the stenting limit zone (4cm
above the ankle joint)
3. Target lesion(s) is located in an area that may be stented without blocking
access to patent main branches
4. Treatment of all above the knee inflow lesion(s) is successful prior to
treatment of the target lesion
5. Guidewire has successfully crossed the target lesion(s)
Exclusion criteria
Pre-Procedure Exclusion Criteria
1. Life expectancy <= 1year
2. Stroke <= 90 days prior to the procedure date
3. Prior or planned major amputation in the target limb
4. Previous surgery in the target vessel(s) (including prior ipsilateral crural
bypass)
5. Previously implanted stent in the target vessel(s)
6. Failed PTA of target lesion/vessel <= 60 days prior to the procedure date
7. Renal failure as measured by a GFR <= 30ml/min per 1.73m2, measured <= 30 days
prior to the procedure date
8. Subject has a platelet count <= 50 or >= 600 X 103/µL <= 30 days prior to the
procedure date
9. NYHA class IV heart failure
10. Subject has symptomatic coronary artery disease (ie, unstable angina)
11. History of myocardial infarction or thrombolysis <= 90 days prior to the
procedure date
12. Non-atherosclerotic disease resulting in occlusion (eg, embolism, Buerger*s
disease, vasculitis)
13. Subject is currently taking Canagliflozin
14. Body Mass Index (BMI) <18
15. Active septicemia or bacteremia
16. Coagulation disorder, including hypercoagulability
17. Contraindication to anticoagulation or antiplatelet therapy
18. Known allergies to stent or stent components
19. Known allergy to contrast media that cannot be adequately pre-medicated
prior to the interventional procedure
20. Known hypersensitivity to heparin
21. Subject is on a high dose of steroids or is on immunosuppressive therapy
22. Subject is currently participating, or plans to participate in, another
investigational trial that may confound the results of this trial (unless
written approval is received from the Boston Scientific study team),
Intra-procedure Exclusion Criteria
1. Angiographic evidence of intra-arterial acute/subacute thrombus or
presence of atheroembolism
2. Treatment required in > 2 target vessels (Note: a target lesion
originating in one vessel and extending into another vessel is considered 1
target vessel)
3. Treatment requires the use of alternate therapy in the target
vessel(s)/lesion(s), (eg, atherectomy, cutting balloon, re-entry devices,
laser, radiation therapy)
4. Aneurysm is present in the target vessel(s)
5. Extremely calcified lesions
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL65790.056.18 |