Peripheral Vascular DiseaseACTIVENCT00753337
The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study
A study testing Assurant® Cobalt Iliac Stent System in people with Peripheral Vascular Disease, run by Medtronic Endovascular at 2 sites in United States.
Trial summary
The objective of this study is to evaluate the safety and efficacy of the Assurant Cobalt Iliac Stent System in the treatment of de novo and restenotic lesions in iliac arteries of subjects with Peripheral Artery Disease (PAD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Assurant® Cobalt Iliac Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2008to Sep 2013
- 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
- The lesion(s) is either de novo or restenotic in nature, located in the common iliac artery and/or the external iliac artery;
- The subject is symptomatic (Fontaine stage II or III) with a target lesion stenosis ≥ 50% .
- The target vessel(s) reference diameter is ≥ 6 mm and ≤ 10 mm by visual estimate;
- The lesion length is < 100 mm (10 cm)
Who cannot join
- Excessive peripheral vascular disease(PVD), unresolved fresh thrombus or tortuousity,or heavily calcified.
- Tissue loss in the target extremities.
- The target lesion is in a prosthetic vascular bypass graft or within 1 cm of a graft anastomosis;
- The target lesion is in an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion.
- The lesion requires treatment other than percutaneous transluminal angioplasty (PTA) prior to stent placement;
- Other lesions requiring treatment or surgery within 30 days of the procedure (pre or post) with the exception of the non-target lesion(s).
Show all 12Show fewer
- Inadequate distal run-off.
- History of bleeding diatheses or coagulopathy or will refuse blood transfusions;
- Creatinine > 2.5 mg/dl
- Platelet count <80,000 cells/mm3 or >700,000 cells/mm3, or a white blood cell (WBC) of <3,000 cells/mm3
- Participation in another investigational device or drug study and has not completed the primary endpoint(s) or that clinically interferes with the study endpoints;
- Previously enrolled in the Study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Michigan Vascular Research Center
Flint, Michigan, 48507
NY Presbyterian Hospital
New York, New York, 10032
About this study
Official title: The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study Using the Medtronic Assurant Cobalt Iliac Balloon-Expandable Stent System
The objective of this study is to evaluate the safety and efficacy of the Assurant Cobalt Iliac Stent System in the treatment of de novo and restenotic lesions in iliac arteries of subjects with Peripheral Artery Disease (PAD).
Read the detailed description
This study is being conducted to collect 9 month safety and efficacy data on the Assurant Cobalt Iliac Stent for all subjects enrolled into the study.
- Conditions
- Peripheral Vascular Disease
- Being tested
- Assurant® Cobalt Iliac Stent System
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assurant® Cobalt Iliac Stent SystemDevice
Iliac Stenting
| Study group | Role | What they receive |
|---|---|---|
| Assurant Cobalt Iliac Stent | Experimental | Assurant® Cobalt Iliac Stent System Receives: Device: Assurant® Cobalt Iliac Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Events (MAE), Measured as Device and/or Procedure Related Death, Target Limb Loss and/or Clinically Driven Target Lesion Revascularization (TLR) or Target Vessel Revascularization (TVR).
Percentage based on number of evaluable subjects for MAE. Subjects are considered unevaluable for MAE to 9 months if a) withdrawn before 240 days without having MAE events or b) lost to follow-up before 240 days without having MAE events and had no contact thereafter or c) any device and/or procedure-unrelated death before 240 days without having MAE events.
Measured: 9 months
Secondary outcomes (10)
Primary Patency Rate at 9 Months
Primary patency was defined as the blood flow through the treated vessel segment into the distal vasculature (e.g. the common femoral artery and/or the deep femoral artery) as evidenced by duplex ultrasound scan at 9 months for all subjects enrolled with evaluable duplex scans.
Measured: 9 months
Device Success
Device Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.
Measured: 9 months
Lesion Success
Lesion Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using any percutaneous method such as baloon angioplasy or other stent.
Measured: 9 months
Procedure Success
Procedure Success defined as angiographic evidence of <30% final residual stenosis of the target lesion after stent placement and no occurrence of a procedure related MAE prior to hospital discharge (for subjects with more than one lesion stented the worse case is counted)
Measured: 9 months
Clinical Success
Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement.
Measured: 30 days
Clinical Success
Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement.
Measured: 9 months
Hemodynamic Success
Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) > 0.10 over pre-procedure level and not deteriorated by > 0.15 from first post-procedure level.
Measured: 30 days
Hemodynamic Success
Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) > 0.10 over pre-procedure level and not deteriorated by > 0.15 from first post-procedure level.
Measured: 9 months
All Cause Mortality
Subjects are considered unevaluable for all cause mortality at 30 days if a) withdrawn before 25 days or b) lost to follow-up before 25 days and had no contact thereafter.
Measured: 30 days
All Cause Mortality
Subjects are considered unevaluable for all cause mortality at 9 months if a) withdrawn before 240 days or b) lost to follow-up before 240 days and had no contact thereafter.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionFeb 2011
- Study completionSep 2013
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 (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- 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
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert G Molnar, MD, Principal investigator, Michigan Vascular Research CenterWilliam Gray, MD, Principal investigator, NY Presbyterian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753337
- Sponsor's protocol ID
- IP085
- Acronym
- ACTIVE
- Status last verified
- Feb 2016
- First submitted
- 15 Sep 2008
- Last updated
- 4 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Molnar RG, Gray WA; ACTIVE Trial Investigators. Sustained patency and clinical improvement following treatment of atherosclerotic iliac artery disease using the Assurant cobalt iliac balloon-expandable stent system. J Endovasc Ther. 2013 Feb;20(1):94-103. doi: 10.1583/12-4010.1.
PubMed 23391088
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study Using the Medtronic Assurant Cobalt Iliac Balloon-Expandable Stent System
- ClinicalTrials.gov ID
- NCT00753337
- Acronym / sponsor ID
- ACTIVE / IP085
- Conditions
- Peripheral Vascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 Sep 2008 (estimated)
- Results
- Posted 30 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and efficacy of the Assurant Cobalt Iliac Stent System in the treatment of de novo and restenotic lesions in iliac arteries of subjects with Peripheral Artery Disease (PAD).
Detailed description
This study is being conducted to collect 9 month safety and efficacy data on the Assurant Cobalt Iliac Stent for all subjects enrolled into the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assurant Cobalt Iliac Stent | Experimental | Device: Assurant® Cobalt Iliac Stent SystemAssurant® Cobalt Iliac Stent System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The lesion(s) is either de novo or restenotic in nature, located in the common iliac artery and/or the external iliac artery;
- The subject is symptomatic (Fontaine stage II or III) with a target lesion stenosis ≥ 50% .
- The target vessel(s) reference diameter is ≥ 6 mm and ≤ 10 mm by visual estimate;
- The lesion length is < 100 mm (10 cm)
Key exclusion criteria (12 listed)
- Excessive peripheral vascular disease(PVD), unresolved fresh thrombus or tortuousity,or heavily calcified.
- Tissue loss in the target extremities.
- The target lesion is in a prosthetic vascular bypass graft or within 1 cm of a graft anastomosis;
- The target lesion is in an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion.
- The lesion requires treatment other than percutaneous transluminal angioplasty (PTA) prior to stent placement;
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 |
|---|---|---|
| Assurant® Cobalt Iliac Stent SystemIliac Stenting | Device | Assurant Cobalt Iliac Stent |
Primary outcome
Major Adverse Events (MAE), Measured as Device and/or Procedure Related Death, Target Limb Loss and/or Clinically Driven Target Lesion Revascularization (TLR) or Target Vessel Revascularization (TVR).
Time frame: 9 months
Percentage based on number of evaluable subjects for MAE. Subjects are considered unevaluable for MAE to 9 months if a) withdrawn before 240 days without having MAE events or b) lost to follow-up before 240 days without having MAE events and had no contact thereafter or c) any device and/or procedure-unrelated death before 240 days without having MAE events.
10 secondary outcomes
Primary Patency Rate at 9 Months
Time frame: 9 months
Device Success
Time frame: 9 months
Lesion Success
Time frame: 9 months
Procedure Success
Time frame: 9 months
Clinical Success
Time frame: 30 days
Clinical Success
Time frame: 9 months
Hemodynamic Success
Time frame: 30 days
Hemodynamic Success
Time frame: 9 months
All Cause Mortality
Time frame: 30 days
All Cause Mortality
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23391088Molnar RG, Gray WA; ACTIVE Trial Investigators. Sustained patency and clinical improvement following treatment of atherosclerotic iliac artery disease using the Assurant cobalt iliac balloon-expandable stent system. J Endovasc Ther. 2013 Feb;20(1):94-103. doi: 10.1583/12-4010.1.
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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.
Robert G Molnar, MD principal investigator
Michigan Vascular Research Center
William Gray, MD principal investigator
NY Presbyterian Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assurant® Cobalt Iliac Stent System in people with Peripheral Vascular Disease, run by Medtronic Endovascular at 2 sites in United States.
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 4 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 4 Apr 2016. 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 United States. 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 30 Dec 2013). 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?
Major Adverse Events (MAE), Measured as Device and/or Procedure Related Death, Target Limb Loss and/or Clinically Driven Target Lesion Revascularization (TLR) or Target Vessel Revascularization (TVR). (time frame: 9 months). 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 NCT00753337, which also lists 1 linked publication.
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 4 Apr 2016.