Critical Limb IschemiaTOBABTKNCT02235675
Tack Optimized Balloon Angioplasty Below the Knee (TOBA - BTK) Study
A study testing Tack-It Endovascular System in people with Critical Limb Ischemia and Peripheral Artery Disease, run by Philips Clinical & Medical Affairs Global at 1 site in Austria.
Trial summary
Multi-center study to optimize below the knee (BTK) balloon angioplasty results by creating tissue apposition in peripheral arteries with Reference Vessel Diameter's (RVD) ranging from 1.5mm to 4.5mm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia, Peripheral Artery Disease
- What is being tested?
- Tack-It Endovascular System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2013to Feb 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of subject is >18
- Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the consent form
- Subject has critical limb ischemia (CLI)
- Subject has Rutherford Clinical Category 4-5. (hemodynamic reference)
- Reference vessel diameter below the knee (BTK) is between 1.5mm and 4.5mm (inclusive).
- De-novo target lesion(s) has stenosis >70%.
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- Must be able to perform PTA. The PTA must result in a dissection Type A - F at some location along the treatment site.
- Any vessel intervened on must have distal reconstitution above the ankle.
- Inflow Iliac, SFA and Popliteal lesions can be treated during the same procedure using standard angioplasty and/or an approved device. These inflow lesions must be treated first, prior to consideration of treatment of BTK lesions. The patient can be enrolled if the inflow lesions are treated with good angiographic results (must have <30% residual stenosis and no evidence of embolization).
Who cannot join
- The subject has a lesion on the plantar surface of the heel or over the Achilles tendon or has exposed calcaneus.
- The subject has extensive forefoot gangrene / ischemic ulcer that cannot be resolved with standard metatarsal amputation.
- Previous treatment failure of inflow arteries (Iliac, SFA and Popliteal)
- Subject with below knee bypass.
- Subject has significant stenosis or occlusion of inflow vessels tract (proximal disease) not successfully treated (>30% residual stenosis and/or complication of the procedure) prior to BTK angioplasty and patient enrollment.
- Subject is permanently wheel-chair bound or bedridden.
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- Subject has an allergy to contrast medium that cannot be pretreated.
- Episode of acute limb ischemia within the previous 30 days.
- Subject is undergoing atherectomy in the target limb or cryoplasty or stenting of BTK treatment site.
- Subject has a systemic infection with positive blood cultures/bacteremia within one week.
- Subject has undrained pus or spreading wet gangrene in the foot that is not controlled at the time of revascularization procedure.
- Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
- Myocardial infarction within 30 days prior to enrollment.
- History of stroke within 180 days prior to enrollment.
- Subject has acute or chronic renal disease (e.g., as measured by a serum creatinine of >2.5 mg/dL or >220 umol/L).
- Subject has a known hypersensitivity or contraindication to nitinol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Multicenter Tack Optimized Balloon Angioplasty Below the Knee (TOBA - BTK) Study for Infrapopliteal Arteries Using the Tack-It Endovascular System™
Multi-center study to optimize below the knee (BTK) balloon angioplasty results by creating tissue apposition in peripheral arteries with Reference Vessel Diameter's (RVD) ranging from 1.5mm to 4.5mm.
Read the detailed description
This first in man (FIM) study is to collect data in support of the safety and performance of the Intact Vascular Tack-It Endovascular System™ for tissue apposition to optimize balloon angioplasty.
Study primary endpoints:
Safety: Composite of Major Adverse Limb Events (MALE) and Peri-procedural Death (POD), assessed at 1 month. Endpoint includes any of the following:
- Major amputation - amputation above the ankle
- Re-intervention (surgical or endovascular) in the target limb
- Procedure-related death - any death within 1 month of the index procedure or any MALE
Device Success: The achievement of successful delivery and deployment of the study device(s) at the intended target site(s) and successful withdrawal of the delivery catheter.
Technical Success: Device success (defined above) and the ability of the Tack to resolve post-PTA dissection, demonstrating angiographic patency at the conclusion of the procedure.
Clinical Success: Ability of the Tack to resolve post-PTA dissection and achieve patency at the conclusion of the procedure, without procedure related complications within 48 hours after the index procedure or at hospital discharge, whichever is sooner.
Study secondary endpoints:
The following events will be assessed at 3, 6 and 12 months:
- All-cause mortality
- Amputation of the limb (above the ankle)
- Amputation free survival
- Clinically driven target vessel revascularization (TVR)
- Clinically driven target lesion revascularization (TLR)
- Changes in Rutherford Clinical Category from baseline
The following parameters will be assessed at 1, 3, 6 and 12 months:
- Maintenance of luminal patency of the target lesion by TBI (≤0.15 decrease) as compared to the baseline TBI obtained prior to discharge
- Doppler Exam (presence of signal)
Study observational endpoint:
The following parameter will be assessed at 6 months (Per local Standard of Care):
- Angiographic percent diameter stenosis
- Conditions
- Critical Limb Ischemia, Peripheral Artery Disease
- Being tested
- Tack-It Endovascular System
- Keywords
- Angioplasty, Peripheral Artery Disease, Critical Limb Ischemia, CLI, PAD
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tack-It Endovascular SystemDevice
Also called Tack-It Dissection Repair, Intact Vascular Tack-It, Tack-It, Tack
Repair of post-PTA dissections using the Intact Vascular Tack-It implant.
| Study group | Role | What they receive |
|---|---|---|
| Tack-It | Experimental | Implant of the Intact Vascular Tack-It Endovascular System to repair post angioplasty dissections. Receives: Device: Tack-It Endovascular System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoints
Safety: Composite of Major Adverse Limb Events (MALE) and Peri-procedural Death (POD), assessed at 1 month. Endpoint includes any of the following:
- Major amputation - amputation above the ankle
- Re-intervention (surgical or endovascular) in the target limb
- Procedure-related death - any death within 1 month of the index procedure or any MALE
Measured: 30 Days
Secondary outcomes (1)
Secondary Endpoints
The composite of following events will be assessed at 3, 6 and 12 months or as noted:
- All-cause mortality
- Amputation of the limb (above the ankle)
- Amputation free survival
- Clinically driven target vessel revascularization (TVR)
- Clinically driven target lesion revascularization (TLR)
- Changes in Rutherford Clinical Category from baseline
- Maintenance of luminal patency of the target lesion by TBI (≤0.15 decrease) as compared to the baseline TBI obtained prior to discharge at 1,3,6 and 12 months.
- Doppler Exam (presence of signal at 1,3,6 and 12 months)
Measured: 1, 3, 6 and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startDec 2013
- Primary completionFeb 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe sponsor's other registered studies.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marianne Brodmann, MD, Principal investigator, MEDIZINISCHE UNIVERSITAT GRAZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235675
- Sponsor's protocol ID
- TD 0109
- Acronym
- TOBABTK
- Status last verified
- Apr 2021
- First submitted
- 4 Sep 2014
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter Tack Optimized Balloon Angioplasty Below the Knee (TOBA - BTK) Study for Infrapopliteal Arteries Using the Tack-It Endovascular System™
- ClinicalTrials.gov ID
- NCT02235675
- Acronym / sponsor ID
- TOBABTK / TD 0109
- Conditions
- Critical Limb Ischemia, Peripheral Artery Disease
- Keywords
- Angioplasty, Peripheral Artery Disease, Critical Limb Ischemia, CLI, PAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 10 Sep 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.
Multi-center study to optimize below the knee (BTK) balloon angioplasty results by creating tissue apposition in peripheral arteries with Reference Vessel Diameter's (RVD) ranging from 1.5mm to 4.5mm.
Detailed description
This first in man (FIM) study is to collect data in support of the safety and performance of the Intact Vascular Tack-It Endovascular System™ for tissue apposition to optimize balloon angioplasty.
Study primary endpoints:
Safety: Composite of Major Adverse Limb Events (MALE) and Peri-procedural Death (POD), assessed at 1 month. Endpoint includes any of the following:
- Major amputation - amputation above the ankle
- Re-intervention (surgical or endovascular) in the target limb
- Procedure-related death - any death within 1 month of the index procedure or any MALE
Device Success: The achievement of successful delivery and deployment of the study device(s) at the intended target site(s) and successful withdrawal of the delivery catheter.
Technical Success: Device success (defined above) and the ability of the Tack to resolve post-PTA dissection, demonstrating angiographic patency at the conclusion of the procedure.
Clinical Success: Ability of the Tack to resolve post-PTA dissection and achieve patency at the conclusion of the procedure, without procedure related complications within 48 hours after the index procedure or at hospital discharge, whichever is sooner.
Study secondary endpoints:
The following events will be assessed at 3, 6 and 12 months:
- All-cause mortality
- Amputation of the limb (above the ankle)
- Amputation free survival
- Clinically driven target vessel revascularization (TVR)
- Clinically driven target lesion revascularization (TLR)
- Changes in Rutherford Clinical Category from baseline
The following parameters will be assessed at 1, 3, 6 and 12 months:
- Maintenance of luminal patency of the target lesion by TBI (≤0.15 decrease) as compared to the baseline TBI obtained prior to discharge
- Doppler Exam (presence of signal)
Study observational endpoint:
The following parameter will be assessed at 6 months (Per local Standard of Care):
- Angiographic percent diameter stenosis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tack-It | Experimental | Device: Tack-It Endovascular SystemImplant of the Intact Vascular Tack-It Endovascular System to repair post angioplasty dissections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age of subject is >18
- Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the consent form
- Subject has critical limb ischemia (CLI)
- Subject has Rutherford Clinical Category 4-5. (hemodynamic reference)
- Reference vessel diameter below the knee (BTK) is between 1.5mm and 4.5mm (inclusive).
Key exclusion criteria (16 listed)
- The subject has a lesion on the plantar surface of the heel or over the Achilles tendon or has exposed calcaneus.
- The subject has extensive forefoot gangrene / ischemic ulcer that cannot be resolved with standard metatarsal amputation.
- Previous treatment failure of inflow arteries (Iliac, SFA and Popliteal)
- Subject with below knee bypass.
- Subject has significant stenosis or occlusion of inflow vessels tract (proximal disease) not successfully treated (>30% residual stenosis and/or complication of the procedure) prior to BTK angioplasty and patient enrollment.
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 |
|---|---|---|
| Tack-It Endovascular SystemAlso: Tack-It Dissection Repair, Intact Vascular Tack-It, Tack-It, TackRepair of post-PTA dissections using the Intact Vascular Tack-It implant. | Device | Tack-It |
Primary outcome
Primary Endpoints
Time frame: 30 Days
Safety: Composite of Major Adverse Limb Events (MALE) and Peri-procedural Death (POD), assessed at 1 month. Endpoint includes any of the following: * Major amputation - amputation above the ankle * Re-intervention (surgical or endovascular) in the target limb * Procedure-related death - any death within 1 month of the index procedure or any MALE
1 secondary outcome
Secondary Endpoints
Time frame: 1, 3, 6 and 12 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 5 Apr 2021.
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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.
Marianne Brodmann, MD principal investigator
MEDIZINISCHE UNIVERSITAT GRAZ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tack-It Endovascular System in people with Critical Limb Ischemia and Peripheral Artery Disease, run by Philips Clinical & Medical Affairs Global at 1 site in Austria.
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 9 inclusion and 16 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 5 Apr 2021. 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 Austria. 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?
Primary Endpoints (time frame: 30 Days). 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 5 Apr 2021.