Critical Limb IschemiaNCT02044003
Safety & Feasibility Study of Tack-It Device for Vessel Dissection Repair
A study testing Innovasc Tack Intravascular Staple System (Tack) in people with Critical Limb Ischemia and Peripheral Artery Disease, run by Philips Clinical & Medical Affairs Global at 2 sites in Paraguay.
Trial summary
The study is intended to evaluate the safety and feasibility of using the Intact Vascular (Innovasc) Tack-It Endovascular Dissection Repair System (Tack Intravascular Staple System) in patients with vascular flaps in the infrainguinal due post-angioplasty dissection. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Critical Limb Ischemia, Peripheral Artery Disease
- What is being tested?
- Innovasc Tack Intravascular Staple System (Tack)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesParaguay
- Study dates
- Dec 2009to Dec 2011
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 and < 85 years
- Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
- Patient has documented chronic limb ischemia with Rutherford Category 2, 3, 4, or 5. Clinical conditions of claudication or rest pain or ischemic ulceration or minor gangrene as diagnosed by the investigator
- Reference vessel diameter between 2 and 7mm
- Target lesion is not severely calcified
- At least one patent tibial runoff vessel is present.
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- Patient has patent iliac or femoral arteries that allow endovascular access to the site with the Introducer Sheath or Delivery Catheter or these can be treated at the time of the procedure and achieve a <30% residual stenosis at each inflow lesion.
- Ability to pass the guidewire across the atherosclerotic lesion.
- No evidence of aneurysm or acute thrombus in target vessel.
Who cannot join
- Severe or infected gangrene of the lower extremity
- Planned major amputation
- Previously implanted stent at the treatment site
- Patient is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization.
- Patient has connective tissue disease (e.g., Marfan's syndrome).
- Inability to tolerate antiplatelet agents
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- Patient is hypercoagulable
- Patient has allergy to vascular contrast for which they cannot be premedicated.
- Patient is in acute renal failure or chronic renal insufficiency or failure as measured by a serum creatinine of >2.2 mg/dL.
- Patient has active systemic infection
- Patient has a less than one year life expectancy.
- Patient is pregnant or nursing.
Trial locations and contacts
2 sites in 1 country.
Paraguay2 sites
Italian Hospital (Final treatment hospital and all follow-up)
Asunción
Santa Clara Medical Center (initial treatment hospital)
Asunción
About this study
Official title: Safety & Feasibility Study of the Innovasc Tack Intravascular Staple System (Tack) for Securing Vascular Flaps Resulting From Balloon Angioplasty in the Infrainguinal Artery(Ies)
The study is intended to evaluate the safety and feasibility of using the Intact Vascular (Innovasc) Tack-It Endovascular Dissection Repair System (Tack Intravascular Staple System) in patients with vascular flaps in the infrainguinal due post-angioplasty dissection.
Read the detailed description
The primary objective of the study is to evaluate the safety of delivery and placement of the Innovasc Tack Intravascular Staple System on vascular flaps in the SFA, created by percutaneous transluminal balloon angioplasty
Safety will be evaluated as the 30-day (or hospital discharge date, whichever is longer) rate of major adverse events defined as the composite endpoint of death, device embolization, the occurrence of surgery related to the device, device related occlusion of the artery, or major unplanned amputation of the ipsilateral lower extremity.
The secondary objective is to evaluate the feasibility of using the Innovasc Tack Intravascular Staple System to permanently secure vascular flaps.
Secondary Evaluation of Feasibility (technical success) of the Innovasc Tack Intravascular Staple System (procedure and device) will be evaluated acutely by the following:
- Feasibility is defined as the ability to accurately place the Plaque Tacks and resolve post-PTA dissection flaps prior to the conclusion of the procedure, as demonstrated by angiography
- Acute technical success: Acute luminal patency during the revascularization procedure using standard angiography which demonstrates that the lumen of the artery at the location of tack implant remains patent at the conclusion of the procedure.
The additional objectives of the study are to assess additional parameters as follows:
- Long term success will be assessed at one (1) month and three (3) months by evaluation of post-implant stability of the Plaque Tack relative to vascular or external landmarks at 30 days and 3 months via standard x-ray.
- Patency at 30 days and 3 months via duplex scanning or angiography, whichever deemed most appropriate for follow up of each individual patient by the principal investigator.
- Conditions
- Critical Limb Ischemia, Peripheral Artery Disease
- Being tested
- Innovasc Tack Intravascular Staple System (Tack)
- Keywords
- angioplasty, dissections
- 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.
Innovasc Tack Intravascular Staple System (Tack)Device
Also called Intact Vascular Tack-It, Tack-It Endovascular Dissection Repair System
Tack-It Dissection repair
| Study group | Role | What they receive |
|---|---|---|
| Post Angioplasty Dissection Repair | Experimental | Implant of Innovasc Tack Intravascular Staple System (Tack) to repair post angioplasty dissections Receives: Device: Innovasc Tack Intravascular Staple System (Tack) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Safety
Safety will be evaluated as the 30-day (or hospital discharge date, whichever is longer) rate of major adverse events defined as the composite endpoint of death, device embolization, the occurrence of surgery related to the device, device related occlusion of the artery, or major unplanned amputation of the ipsilateral lower extremity.
Measured: 30 days
Secondary outcomes (1)
Evaluation of Feasibility
Feasibility (technical success) of the Innovasc Tack Intravascular Staple System (procedure and device) will be evaluated acutely by the following:
- Feasibility is defined as the ability to accurately place the Plaque Tacks and resolve post-PTA dissection flaps prior to the conclusion of the procedure, as demonstrated by angiography
- Acute technical success: Acute luminal patency during the revascularization procedure using standard angiography which demonstrates that the lumen of the artery at the location of tack implant remains patent at the conclusion of the procedure.
Measured: Conclusion of implant procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startDec 2009
- Primary completionMar 2011
- Study completionDec 2011
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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrian Ebner, MD, Principal investigator, Santa Clara Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044003
- Sponsor's protocol ID
- 2009-A
- Status last verified
- Apr 2021
- First submitted
- 17 Jan 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
- Safety & Feasibility Study of the Innovasc Tack Intravascular Staple System (Tack) for Securing Vascular Flaps Resulting From Balloon Angioplasty in the Infrainguinal Artery(Ies)
- ClinicalTrials.gov ID
- NCT02044003
- Acronym / sponsor ID
- 2009-A
- Conditions
- Critical Limb Ischemia, Peripheral Artery Disease
- Keywords
- angioplasty, dissections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Jan 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.
The study is intended to evaluate the safety and feasibility of using the Intact Vascular (Innovasc) Tack-It Endovascular Dissection Repair System (Tack Intravascular Staple System) in patients with vascular flaps in the infrainguinal due post-angioplasty dissection.
Detailed description
The primary objective of the study is to evaluate the safety of delivery and placement of the Innovasc Tack Intravascular Staple System on vascular flaps in the SFA, created by percutaneous transluminal balloon angioplasty
Safety will be evaluated as the 30-day (or hospital discharge date, whichever is longer) rate of major adverse events defined as the composite endpoint of death, device embolization, the occurrence of surgery related to the device, device related occlusion of the artery, or major unplanned amputation of the ipsilateral lower extremity.
The secondary objective is to evaluate the feasibility of using the Innovasc Tack Intravascular Staple System to permanently secure vascular flaps.
Secondary Evaluation of Feasibility (technical success) of the Innovasc Tack Intravascular Staple System (procedure and device) will be evaluated acutely by the following:
- Feasibility is defined as the ability to accurately place the Plaque Tacks and resolve post-PTA dissection flaps prior to the conclusion of the procedure, as demonstrated by angiography
- Acute technical success: Acute luminal patency during the revascularization procedure using standard angiography which demonstrates that the lumen of the artery at the location of tack implant remains patent at the conclusion of the procedure.
The additional objectives of the study are to assess additional parameters as follows:
- Long term success will be assessed at one (1) month and three (3) months by evaluation of post-implant stability of the Plaque Tack relative to vascular or external landmarks at 30 days and 3 months via standard x-ray.
- Patency at 30 days and 3 months via duplex scanning or angiography, whichever deemed most appropriate for follow up of each individual patient by the principal investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post Angioplasty Dissection Repair | Experimental | Device: Innovasc Tack Intravascular Staple System (Tack)Implant of Innovasc Tack Intravascular Staple System (Tack) to repair post angioplasty dissections |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >18 and < 85 years
- Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
- Patient has documented chronic limb ischemia with Rutherford Category 2, 3, 4, or 5. Clinical conditions of claudication or rest pain or ischemic ulceration or minor gangrene as diagnosed by the investigator
- Reference vessel diameter between 2 and 7mm
- Target lesion is not severely calcified
Key exclusion criteria (12 listed)
- Severe or infected gangrene of the lower extremity
- Planned major amputation
- Previously implanted stent at the treatment site
- Patient is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization.
- Patient has connective tissue disease (e.g., Marfan's syndrome).
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 |
|---|---|---|
| Innovasc Tack Intravascular Staple System (Tack)Also: Intact Vascular Tack-It, Tack-It Endovascular Dissection Repair SystemTack-It Dissection repair | Device | Post Angioplasty Dissection Repair |
Primary outcome
Evaluation of Safety
Time frame: 30 days
Safety will be evaluated as the 30-day (or hospital discharge date, whichever is longer) rate of major adverse events defined as the composite endpoint of death, device embolization, the occurrence of surgery related to the device, device related occlusion of the artery, or major unplanned amputation of the ipsilateral lower extremity.
1 secondary outcome
Evaluation of Feasibility
Time frame: Conclusion of implant procedure
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.
Adrian Ebner, MD principal investigator
Santa Clara Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Innovasc Tack Intravascular Staple System (Tack) in people with Critical Limb Ischemia and Peripheral Artery Disease, run by Philips Clinical & Medical Affairs Global at 2 sites in Paraguay.
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 12 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 2 sites in Paraguay. 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?
Evaluation of Safety (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.