Peripheral Arterial DiseaseTOBA II BTKNCT02942966
Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries
A study testing Tack Endovascular System in people with Peripheral Arterial Disease, run by Philips Clinical & Medical Affairs Global at 49 sites in 6 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 the Mid/Distal Popliteal, Tibial, and Peroneal Arteries ranging in diameter from 1.5mm to 4.5mm for the treatment of post percutaneous transluminal balloon angioplasty… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial 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
- 233 participants
- Where
- 49 sitesin 6 countries
- Study dates
- 8 Feb 2017to 10 Jan 2022
- 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
- Males or non-pregnant females ≥ 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 (abstinence is acceptable) through the duration of the study
- Subject 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 (ICF), an impartial witness may sign on behalf of the subject
- Willing to comply with all required follow-up visits
- Rutherford Classification 4 or 5.
- WIfI Wound grade of 0, 1 or modified 2.
- WIfI Foot Infection grade of 0 or 1.
- Estimated life expectancy ≥1 year
Who cannot join
- Is pregnant or refuses to use contraception through the duration of the study
- Previous bypass graft in the target limb
- Acute limb ischemia, defined as symptom onset occurring less than 14 days prior to the index procedure
- Prior or planned above-ankle amputation or complete transmetatarsal amputation to the target limb (this does not apply to ray amputation of ≤2 digits, simple digital amputations or ulcer debridements)
- WIfI Foot Infection grade 2 or 3
- Any systemic infection or immunocompromised state. Patients with an ascending infection/deep foot infection or abscess/white blood count (WBC)≥12,000/or febrile state
Show all 21Show fewer
- Endovascular or surgical procedure (not including diagnostic procedures, planned simple digital amputation or wound debridement) to the target limb less than 30 days prior to or planned for less than 30 days after the index procedure
- Existing stent implant in the target vessel
- Any other endovascular or surgical procedure (not including diagnostic procedures, planned simple digital amputation or wound debridement) less than 14 days prior to the index procedure or planned procedure less than 30 days after 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
- WIfI Wound grade of 2 or 3.
- Any subject in which antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated
- Myocardial infarction, coronary thrombolysis or angina less than 30 days prior to the Index Procedure
- History of stroke or transient ischemic attack (TIA) less than 90 days prior to the Index Procedure
- Currently on dialysis
- Known hypersensitivity or contraindication to nickel-titanium alloy (Nitinol)
- Participating in another ongoing investigational clinical trial in which the subject has not completed the primary endpoint(s)
- 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
- Subject already enrolled into this study
- Restenotic target lesion previously treated by means other than plain balloon angioplasty and/or less than 1 year prior to index procedure.
Trial locations and contacts
49 sites in 6 countries.
49 sites in 6 countries
United States37 sites
New Mexico Heart Institute, PA
Albuquerque, New Mexico, 87102
Piedmont Heart Institute
Atlanta, Georgia, 30309
Lake Washington Vascular, PLLC
Bellevue, Washington, 98004
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Lindner Research Center
Cincinnati, Ohio, 45219
University Hospitals, Cleveland Medical Center
Cleveland, Ohio, 44106
Palmetto Health USC Medical Group
Columbia, South Carolina, 29203
Ohio Health Research Institute
Columbus, Ohio, 43214
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52803
Denver VA Medical Center
Denver, Colorado, 80220
Ascension St. John Hospital
Detroit, Michigan, 48215
Amita Health Cardiovascular Associates
Elk Grove Village, Illinois, 60007
Michigan Vascular Center
Flint, Michigan, 48507
Mission Cardiovascular Research Institute
Fremont, California, 94538
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
Cardiovascular Institute of the South
Houma, Louisiana, 70360
Baylor College of Medicine
Houston, Texas, 77030
Kore Cardiovascular Research
Jackson, Tennessee, 38305
First Coast Cardiovascular Institute
Jacksonville, Florida, 32256
Novant Health Heart and Vascular Institute
Matthews, North Carolina, 28204
North Dallas Research Associates
McKinney, Texas, 75069
Centennial Medical Center
Nashville, Tennessee, 37203
Mission Research Institute
New Braunfels, Texas, 78130
Yale New Haven Hospital
New Haven, Connecticut, 06510
Sentara Vascular Specialists
Norfolk, Virginia, 23507
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
The Heart Hospital Baylor Plano
Plano, Texas, 75093
The Miriam Hospital
Providence, Rhode Island, 02906
Rex Hospital
Raleigh, North Carolina, 27607
WakeMed Hospital
Raleigh, North Carolina, 27609
St. Louis Heart & Vascular
St Louis, Missouri, 63136
Holy Name Medical Center
Teaneck, New Jersey, 07666
Cardiovascular Associates of East Texas
Tyler, Texas, 75701
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Yuma Regional Medical Center
Yuma, Arizona, 85364
Germany7 sites
Karolinen-Hospital
Arnsberg, 59759
Franziskus-Hospital Berlin-Radiology
Berlin, 10787
Westküstenklinikum Heide
Heide, 25746
Universitätsklinikum Leipzig
Leipzig, 04103
Evangelisches Krankenhaus Mülheim an der Ruhr
Mülheim
Krankenhaus Buchholz
Nordheide, 21244
MEDINOS Kliniken des Landkreises Sonneberg GmbH
Sonneberg, 96515
Hungary2 sites
Heart & Vascular Center - Semmelweis University
Budapest, 1122
Bács-Kiskun County Hospital
Kecskemét
About this study
Official title: Tack Optimized Balloon Angioplasty Study for the Below The Knee 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 the Mid/Distal Popliteal, Tibial, and Peroneal Arteries ranging in diameter from 1.5mm to 4.5mm for the treatment of post percutaneous transluminal balloon angioplasty (PTA) dissection(s) requiring repair.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Tack Endovascular System
- Keywords
- Angioplasty, Below the Knee, PAD, Critical Limb Ischemia, Lesion, Claudication
- Medical subject headings
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, 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 below the knee. 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 Participants With Freedom From MALE at 6 Months and POD at 30 Days
Freedom from major adverse limb events (MALE) at 6 months defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death (POD) at 30 days.
Measured: 6 months
Safety - Number of Participants With MALE Plus POD at 30 Days
Major adverse limb events (MALE) at 30 days defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death at 30 days
Measured: 30 days
Secondary outcomes (2)
Patency - Number of Target Lesion(s) Tacked Segment(s) Patent at 6 Months
Target lesion(s) tacked segment(s) patency at 6 months defined as the presence of blood flow using duplex ultrasound. If angiography is available within the 6 month follow-up visit window, it should be used in place of the duplex ultrasound. Evidence of no blood flow within the Tacked segment indicates restenosis/loss of patency.
Measured: 6 months
Target Limb Salvage - Number of Participants With Freedom From Above-Ankle Target Limb Amputation at 6 Months
Target Limb Salvage defined as freedom from any above-ankle target limb amputation at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start8 Feb 2017
- Primary completion11 Jul 2019
- Study completion10 Jan 2022
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial 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
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick J. Geraghty, MD, Principal investigator, Washington University School of Medicine in St. LouisGeorge Adams, MD, Principal investigator, Rex Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942966
- Sponsor's protocol ID
- CA 0137
- Acronym
- TOBA II BTK
- Status last verified
- Apr 2021
- First submitted
- 20 Oct 2016
- Last updated
- 31 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Conte MS, Geraghty PJ, Bradbury AW, Hevelone ND, Lipsitz SR, Moneta GL, Nehler MR, Powell RJ, Sidawy AN. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg. 2009 Dec;50(6):1462-73.e1-3. doi: 10.1016/j.jvs.2009.09.044. Epub 2009 Nov 7.
PubMed 19897335Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12.
PubMed 24126108Adams GL, Lichtenberg M, Wissgott C, Schmidt A, Tarra T, Matricardi S, Geraghty PJ. Twenty-Four Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries. J Endovasc Ther. 2023 Jun;30(3):393-400. doi: 10.1177/15266028221083462. Epub 2022 Mar 30.
PubMed 35352604Geraghty PJ, Adams GL, Schmidt A, Lichtenberg M, Wissgott C, Armstrong EJ, Hertting K; TOBA II BTK investigators. Twelve-Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries (TOBA II BTK). J Endovasc Ther. 2020 Aug;27(4):626-636. doi: 10.1177/1526602820944402.
PubMed 35156451
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tack Optimized Balloon Angioplasty Study for the Below The Knee Arteries Using the Tack Endovascular System®
- ClinicalTrials.gov ID
- NCT02942966
- Acronym / sponsor ID
- TOBA II BTK / CA 0137
- Conditions
- Peripheral Arterial Disease
- Keywords
- Angioplasty, Below the Knee, PAD, Critical Limb Ischemia, Lesion, Claudication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 11 Jul 2019 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Posted 28 Jul 2021
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 the Mid/Distal Popliteal, Tibial, and Peroneal Arteries ranging in diameter from 1.5mm to 4.5mm for the treatment of post percutaneous transluminal balloon angioplasty (PTA) dissection(s) requiring repair.
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 below the knee. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males or non-pregnant females ≥ 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 (abstinence is acceptable) through the duration of the study
- Subject 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 (ICF), an impartial witness may sign on behalf of the subject
- Willing to comply with all required follow-up visits
- Rutherford Classification 4 or 5.
Key exclusion criteria (21 listed)
- Is pregnant or refuses to use contraception through the duration of the study
- Previous bypass graft in the target limb
- Acute limb ischemia, defined as symptom onset occurring less than 14 days prior to the index procedure
- Prior or planned above-ankle amputation or complete transmetatarsal amputation to the target limb (this does not apply to ray amputation of ≤2 digits, simple digital amputations or ulcer debridements)
- WIfI Foot Infection grade 2 or 3
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 Participants With Freedom From MALE at 6 Months and POD at 30 Days
Time frame: 6 months
Freedom from major adverse limb events (MALE) at 6 months defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death (POD) at 30 days.
Safety - Number of Participants With MALE Plus POD at 30 Days
Time frame: 30 days
Major adverse limb events (MALE) at 30 days defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death at 30 days
2 secondary outcomes
Patency - Number of Target Lesion(s) Tacked Segment(s) Patent at 6 Months
Time frame: 6 months
Target Limb Salvage - Number of Participants With Freedom From Above-Ankle Target Limb Amputation at 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19897335Conte MS, Geraghty PJ, Bradbury AW, Hevelone ND, Lipsitz SR, Moneta GL, Nehler MR, Powell RJ, Sidawy AN. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg. 2009 Dec;50(6):1462-73.e1-3. doi: 10.1016/j.jvs.2009.09.044. Epub 2009 Nov 7.
- Background: PubMed 24126108Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12.
- Derived from this study: PubMed 35352604Adams GL, Lichtenberg M, Wissgott C, Schmidt A, Tarra T, Matricardi S, Geraghty PJ. Twenty-Four Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries. J Endovasc Ther. 2023 Jun;30(3):393-400. doi: 10.1177/15266028221083462. Epub 2022 Mar 30.
- Derived from this study: PubMed 35156451Geraghty PJ, Adams GL, Schmidt A, Lichtenberg M, Wissgott C, Armstrong EJ, Hertting K; TOBA II BTK investigators. Twelve-Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries (TOBA II BTK). J Endovasc Ther. 2020 Aug;27(4):626-636. doi: 10.1177/1526602820944402.
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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.
Patrick J. Geraghty, MD principal investigator
Washington University School of Medicine in St. Louis
George Adams, MD principal investigator
Rex Hospital
49 sites in 6 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 Arterial Disease, run by Philips Clinical & Medical Affairs Global at 49 sites in 6 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 8 inclusion and 21 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 31 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Germany, Hungary, Austria, Czechia and 1 more country. 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 28 Jul 2021). 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 Participants With Freedom From MALE at 6 Months and POD at 30 Days (time frame: 6 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?
On the ClinicalTrials.gov record for NCT02942966, which also lists 4 linked publications.
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 31 Jan 2022.