Peripheral Artery DiseaseTOBA IINCT02522884
Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries
A study testing Tack Endovascular System in people with Peripheral Artery Disease, run by Philips Clinical & Medical Affairs Global at 39 sites in 3 countries.
Trial summary
This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in subjects with post-balloon angioplasty (post-PTA) dissection(s) type(s) A through F in the superficial femoral and proximal popliteal arteries ranging in diameter from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Tack Endovascular System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 39 sitesin 3 countries
- Study dates
- Sep 2015to Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject must meet all of the following inclusion criteria to be eligible for enrollment:
- Male or non-pregnant Female ≥ 18 years of age at the time of consent
- Female subjects of childbearing potential must have a negative pregnancy test prior to treatment and must use some form of contraception through the duration of the study (abstinence is acceptable)
- Target limb requires no additional treatment aside from the target lesion and the iliac artery(ies) during the index procedure
- Subject or has been informed of and understands the nature of the study and provides signed informed consent to participate in the study. If the subject possesses the ability to understand and provide informed consent but due to physical inability, the subject cannot sign the Informed Consent Form, an impartial witness may sign on behalf of the subject
- Willing to comply with all required follow-up visits
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- Rutherford Classification 2, 3 or 4
- Estimated life expectancy >1 year
- Eligible for standard surgical repair, if necessary
- Subject is ambulatory (assistive devices such as a cane or walker is acceptable)
Who cannot join
- Subject must NOT meet any of the following exclusion criteria to be eligible for enrollment:
- Rutherford Classification 0, 1, 5 or 6
- Is pregnant or refuses to use contraception through the duration of the study
- Previous infrainguinal bypass graft in the target limb
- Planned amputation on the target limb
- Systemic infection or Infection within the target limb and/or immunocompromised
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- Endovascular or surgical procedure (not including diagnostic procedures) on the target limb within 30 days prior to or within 30 days after the index procedure
- Endovascular or surgical procedure (not including diagnostic procedures) on the non-target limb within 14 days prior to the index procedure or planned procedure within 30 days after the index procedure
- Prior coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) procedure within 30 days prior to the index procedure or planned CABG/PCI within 30 days after the index procedure
- Any other previous or planned surgical or endovascular procedure (not including diagnostic procedures) within 14 days prior to or 30 days post index procedure
- Planned atherectomy, cryoplasty, stenting or any other treatment (with the exception of a crossing device) of the target lesion other than PTA during the index procedure
- Known coagulopathy, hypercoagulable state, bleeding diathesis, other blood disorder, or a platelet count less than 80,000/microliter or greater than 500,000/microliter
- Known hypersensitivity or allergy to antiplatelet or anticoagulant therapy
- Myocardial infarction within 30 days prior to enrollment
- History of stroke within 90 days prior to enrollment
- Serum creatinine of >2.5 mg/dL
- Requires treatment of tibial or outflow vessels at the index procedure, which include the P2 and P3 segments of the popliteal artery and the tibioperoneal vessels
- Known hypersensitivity or contraindication to nickel-titanium alloy (Nitinol)
- Participating in another ongoing investigational clinical trial that has not completed its primary endpoint
- Has other comorbidities that, in the opinion of the investigator, would preclude them from receiving this treatment and/or participating in study-required follow-up assessments
- Known hypersensitivity or allergy to contrast agents that cannot be medically managed
- Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved
Trial locations and contacts
39 sites in 3 countries.
39 sites in 3 countries
United States36 sites
New Mexico Heart Institute, PA
Albuquerque, New Mexico, 87102
Cedars Sinai Medical Center
Beverly Hills, California, 90211
Massachusetts General Hospital
Boston, Massachusetts, 02114
Holy Spirit Cardiology
Camp Hill, Pennsylvania, 17011
Medical University of South Carolina
Charleston, South Carolina, 29425
Ohio Health Research Institute
Columbus, Ohio, 43214
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52803
Denver VA Medical Center
Denver, Colorado, 80220
Alexian Brothers Medical Center Heart & Vascular Institute
Elk Grove Village, Illinois, 60007
Mission Cardiovascular Research Institute
Fremont, California, 94538
Florida Research Network, LLC
Gainesville, Florida, 32605
Baylor College of Medicine
Houston, Texas, 77030
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
University of Kansas Medical Center
Kansas City, Kansas, 66226
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660
Adventist Midwest Health
LaGrange, Illinois, 60439
St. Mary Medical Center
Langhorne, Pennsylvania, 19047
Central Arkansas Veteran's Healthcare System
Little Rock, Arkansas, 72205
North Dallas Research Associates
McKinney, Texas, 75069
Mission Research Institute
New Braunfels, Texas, 78130
Yale New Haven Hospital
New Haven, Connecticut, 06510
Sentara Vascular Specialists
Norfolk, Virginia, 23507
St. Joseph Hospital
Orange, California, 92868
Einstein Medical Center Philadelphia
Philadelphia, Pennsylvania, 19141
The Miriam Hospital
Providence, Rhode Island, 02906
NC Heart and Vascular Research
Raleigh, North Carolina, 27607
NC Heart and Vascular Research - WakeMed Raleigh
Raleigh, North Carolina, 27610
North Central Heart
Sioux Falls, South Dakota, 57108
Prairie Education and Research Cooperative
Springfield, Illinois, 62701
Holy Name Medical Center
Teaneck, New Jersey, 07666
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, 17043
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
Metro Health Hospital
Wyoming, Michigan, 49519
Yuma Regional Medical Center
Yuma, Arizona, 85364
Austria2 sites
Medical University Hospital Graz
Graz
Hanusch Krankenhaus
Vienna
About this study
Official title: Tack Optimized Balloon Angioplasty Study for Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System™
This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in subjects with post-balloon angioplasty (post-PTA) dissection(s) type(s) A through F in the superficial femoral and proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm.
- Conditions
- Peripheral Artery Disease
- Being tested
- Tack Endovascular System
- Keywords
- Angioplasty, Peripheral Artery Disease, PAD, Lesion, Claudication
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tack Endovascular SystemDevice
Also called Post-PTA Dissection Repair Implant, Tack Implant, Tack Dissection Repair Device
Repair of post-PTA dissections using the Intact Vascular Tack Endovascular System.
| Study group | Role | What they receive |
|---|---|---|
| Tack Implant | Experimental | Implantation of a Tack using the Intact Vascular Tack Endovascular System for the repair of post angioplasty dissections. Receives: Device: Tack Endovascular System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - Number of Subjects That Met Primary Patency Criteria at 12 Months
Primary patency defined as freedom from Clinical Events Committee (CEC) adjudicated clinically-driven target lesion revascularization (CD-TLR) and freedom from core lab adjudicated duplex ultrasound derived binary restenosis at 12 months (defined as peak systolic velocity ratio (PSVR) >2.5)
Measured: 12 Months
Safety - Number of Subjects That Met the Primary Safety Criteria of Freedom From Major Adverse Events at 30 Days
Freedom from the occurrence of any new-onset major adverse event(s) (MAEs) defined as index limb amputation (above the ankle), CEC adjudicated clinically-driven target lesion revascularization (CD-TLR), or all-cause death at 30 days.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2018
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Artery DiseaseStudies 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
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William A. Gray, MD, Principal investigator, Main Line Health/Lankenau Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522884
- Sponsor's protocol ID
- CA 0119
- Acronym
- TOBA II
- Status last verified
- Apr 2021
- First submitted
- 7 Aug 2015
- Last updated
- 27 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tack Optimized Balloon Angioplasty Study for Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System™
- ClinicalTrials.gov ID
- NCT02522884
- Acronym / sponsor ID
- TOBA II / CA 0119
- Conditions
- Peripheral Artery Disease
- Keywords
- Angioplasty, Peripheral Artery Disease, PAD, Lesion, Claudication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Posted 10 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in subjects with post-balloon angioplasty (post-PTA) dissection(s) type(s) A through F in the superficial femoral and proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tack Implant | Experimental | Device: Tack Endovascular SystemImplantation of a Tack using the Intact Vascular Tack Endovascular System for the repair of 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 (10 listed)
- Subject must meet all of the following inclusion criteria to be eligible for enrollment:
Key exclusion criteria (22 listed)
- Subject must NOT meet any of the following exclusion criteria to be eligible for 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 Endovascular SystemAlso: Post-PTA Dissection Repair Implant, Tack Implant, Tack Dissection Repair DeviceRepair of post-PTA dissections using the Intact Vascular Tack Endovascular System. | Device | Tack Implant |
Primary outcome
Efficacy - Number of Subjects That Met Primary Patency Criteria at 12 Months
Time frame: 12 Months
Primary patency defined as freedom from Clinical Events Committee (CEC) adjudicated clinically-driven target lesion revascularization (CD-TLR) and freedom from core lab adjudicated duplex ultrasound derived binary restenosis at 12 months (defined as peak systolic velocity ratio (PSVR) >2.5)
Safety - Number of Subjects That Met the Primary Safety Criteria of Freedom From Major Adverse Events at 30 Days
Time frame: 30 Days
Freedom from the occurrence of any new-onset major adverse event(s) (MAEs) defined as index limb amputation (above the ankle), CEC adjudicated clinically-driven target lesion revascularization (CD-TLR), or all-cause death at 30 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
William A. Gray, MD principal investigator
Main Line Health/Lankenau Heart Institute
39 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tack Endovascular System in people with Peripheral Artery Disease, run by Philips Clinical & Medical Affairs Global at 39 sites in 3 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 10 inclusion and 22 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 27 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 39 sites in United States, Austria, Netherlands. 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?
Yes. Results are posted in the registry (first posted 10 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy - Number of Subjects That Met Primary Patency Criteria at 12 Months (time frame: 12 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 27 Apr 2021.