Peripheral Vascular DiseasesPhase 4NCT00180505
ASSESS Study: Evaluation of ABSOLUTE™ Stent System for Occluded Arteries
A Phase 4 study testing ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent in people with Peripheral Vascular Diseases, run by Abbott Medical Devices at 13 sites in 7 countries.
Trial summary
The purpose of this study is to investigate the performance of the ABSOLUTE™ .035 peripheral self-expanding stent system in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 13 sitesin 7 countries
- Study dates
- Mar 2005to Oct 2009
- Phase
- Phase 4
- 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
- De novo lesion of the superficial femoral artery (SFA) or proximal popliteal artery within the following parameters:
- 10 mm distal to the origin of the profunda femoris (= 10 mm from the femoral bifurcation in the SFA) and
- 20 mm from the proximal margin of the intercondylar fossa.
- Patients must have symptomatic leg ischemia, requiring treatment of the superficial femoral/proximal popliteal vessel
- Target vessel reference diameter visually estimated to be > 4.0 mm and < 7.0 mm
- Target lesion length visually estimated to be > 40 mm and < 200 mm
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- If the patient has a contralateral SFA or contralateral proximal popliteal lesion, this lesion can be treated as a non-target lesion. The time and way of treatment of the non-target lesion will be left up to the discretion of the investigator
- At least one-vessel run-off to the foot confirmed by baseline angiography
- Patent common iliac artery, common femoral artery and profunda confirmed by baseline angiography. The patent common iliac artery can be obtained during the index procedure by a successful treatment prior to the treatment of the target lesion. Successful treatment being defined as attainment of final residual diameter stenosis of < 30% without death, stroke, bleeding requiring > 2 units transfusion, or any other complication which was device or procedure related.
- Patient is acceptable candidate for femoral-popliteal artery bypass surgery
Who cannot join
- Previous ipsilateral femoro-popliteal or femoro-tibial surgery
- Presence of a stent in the target vessel
- Prescheduled staged procedures of multiple lesions within the ipsilateral iliac or ipsilateral popliteal arteries within 30 days after the index procedure
- Co-existing aneurysmal disease of the abdominal aorta or iliac or popliteal arteries
- Acute thrombophlebitis or deep vein thrombus
- Any immunosuppressive disorders, groin infection, or acute systemic infection due to any cause or any viral or bacterial infection
Show all 9Show fewer
- Significant gastrointestinal (GI) bleed within the past month that would contraindicate the use of anti-platelet therapy
- Hemodynamic instability
- Target lesion is restenotic from previous intervention
Trial locations and contacts
13 sites in 7 countries.
13 sites in 7 countries
Germany3 sites
Herzzentrum Bad Krozingen
Bad Krozingen, 79189
Universitäres Herz & Gefässzentrum Hamburg
Hamburg, 22527
Herzzentrum Leipzig
Leipzig, 04289
Italy3 sites
Nuovo Ospedale Civile Sant' Agostino
Baggiovara (Modena), 41100
Casa di Cura Montevergine
Mercogliano, 83013
Policlinico San Matteo
Pavia, 27100
Austria2 sites
Landeskrankenhaus Klagenfurt
Klagenfurt, 9026
Allgemeines Krankenhaus der Stadt Wien (AKH Wien)
Vienna, 1090
France2 sites
Polyclinique Louis Pasteur
Essey-lès-Nancy, 54270
Hôpital Pontchaillou- CHU
Rennes, 35033
About this study
Official title: Non-Randomized, Prospective, Multi-center Evaluation of the ABSOLUTE™ .035 Peripheral Self-Expanding Stent System for Occluded or Stenotic Superficial Femoral or Proximal Popliteal Arteries
The purpose of this study is to investigate the performance of the ABSOLUTE™ .035 peripheral self-expanding stent system in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries.
Read the detailed description
The treatment of stenosis in superficial femoral arteries and/or proximal popliteal arteries with stenting is associated with high restenosis rates, especially with the first generation stents (stainless steel). Currently, self-expandable nitinol stents are commercialized which lead to higher primary patency rates as compared to the first generation stents, even in longer lesions. However, until now most data available are retrospective and uni-center. The ASSESS study is a prospective multi-center study investigating the performance (restenosis rate, patency rates) of the ABSOLUTE™. 035 peripheral self-expandable stent in longer lesions (lesion length from 4.00 mm to 200.00 mm).
Moreover, literature shows stent fracture in nitinol stents, with a possible clinical relationship. For this reason, the ASSESS study will analyze the stent fractures of the ABSOLUTE™ stent, and a possible relationship between stent fracture and restenosis.
- Conditions
- Peripheral Vascular Diseases
- Being tested
- ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent
- Keywords
- Peripheral Artery Disease, Restenosis Rate, Patency Rates, Self-Expandable Nitinol Stents, Stent Fractures
- Medical subject headings
- Peripheral Vascular Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABSOLUTE™: Self-Expandable Peripheral Nitinol StentDevice
A prospective, non-randomized, multi-center study to investigate the performance of the ABSOLUTE™ .035 Peripheral Self-Expanding Stent System (ABSOLUTE™ Stent) in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries. Follow up at 30, 180, 270, 365 days and 2 years.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | The purpose of the ASSESS Registry is to investigate the performance of the ABSOLUTE™ .035 Peripheral Self-Expanding Stent System (ABSOLUTE™ Stent) in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries. Receives: Device: ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restenosis rate (diameter stenosis ≥ 50% as determined by Duplex ultrasound).
Measured: At 180 days
Secondary outcomes (8)
Clinically driven target lesion revascularization
Measured: at 12 and 24 month follow-up
Target lesion primary, primary assisted and secondary patency rates
Measured: at 6, 12 and 24 month follow-up
Major complications
Measured: at 1, 6, 12 and 24 month follow-up
Angiographic binary restenosis rate in a subset of patients
Measured: at 9 month follow-up
Device and procedure success
Measured: Acute
Vascular and bleeding complications (local and puncture site)
Measured: 1, 6, 12, 24 months
Stent fracture determined by biplane X-ray
Measured: at 12 month follow-up
Restenosis rate at 365 days, and 2 years (diameter stenosis ≥ 50% as determined by Duplex ultrasound)
Measured: 365 days and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionMar 2006
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Zeller, M.D., Principal investigator, Herzzentrum Bad Krozingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180505
- Sponsor's protocol ID
- 04-100
- Status last verified
- Feb 2010
- First submitted
- 13 Sep 2005
- Last updated
- 24 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Randomized, Prospective, Multi-center Evaluation of the ABSOLUTE™ .035 Peripheral Self-Expanding Stent System for Occluded or Stenotic Superficial Femoral or Proximal Popliteal Arteries
- ClinicalTrials.gov ID
- NCT00180505
- Acronym / sponsor ID
- 04-100
- Conditions
- Peripheral Vascular Diseases
- Keywords
- Peripheral Artery Disease, Restenosis Rate, Patency Rates, Self-Expandable Nitinol Stents, Stent Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 16 Sep 2005 (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 purpose of this study is to investigate the performance of the ABSOLUTE™ .035 peripheral self-expanding stent system in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries.
Detailed description
The treatment of stenosis in superficial femoral arteries and/or proximal popliteal arteries with stenting is associated with high restenosis rates, especially with the first generation stents (stainless steel). Currently, self-expandable nitinol stents are commercialized which lead to higher primary patency rates as compared to the first generation stents, even in longer lesions. However, until now most data available are retrospective and uni-center. The ASSESS study is a prospective multi-center study investigating the performance (restenosis rate, patency rates) of the ABSOLUTE™. 035 peripheral self-expandable stent in longer lesions (lesion length from 4.00 mm to 200.00 mm).
Moreover, literature shows stent fracture in nitinol stents, with a possible clinical relationship. For this reason, the ASSESS study will analyze the stent fractures of the ABSOLUTE™ stent, and a possible relationship between stent fracture and restenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: ABSOLUTE™: Self-Expandable Peripheral Nitinol StentThe purpose of the ASSESS Registry is to investigate the performance of the ABSOLUTE™ .035 Peripheral Self-Expanding Stent System (ABSOLUTE™ Stent) in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- De novo lesion of the superficial femoral artery (SFA) or proximal popliteal artery within the following parameters:
- Patients must have symptomatic leg ischemia, requiring treatment of the superficial femoral/proximal popliteal vessel
- Target vessel reference diameter visually estimated to be > 4.0 mm and < 7.0 mm
- Target lesion length visually estimated to be > 40 mm and < 200 mm
- If the patient has a contralateral SFA or contralateral proximal popliteal lesion, this lesion can be treated as a non-target lesion. The time and way of treatment of the non-target lesion will be left up to the discretion of the investigator
Key exclusion criteria (9 listed)
- Previous ipsilateral femoro-popliteal or femoro-tibial surgery
- Presence of a stent in the target vessel
- Prescheduled staged procedures of multiple lesions within the ipsilateral iliac or ipsilateral popliteal arteries within 30 days after the index procedure
- Co-existing aneurysmal disease of the abdominal aorta or iliac or popliteal arteries
- Acute thrombophlebitis or deep vein thrombus
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 |
|---|---|---|
| ABSOLUTE™: Self-Expandable Peripheral Nitinol StentA prospective, non-randomized, multi-center study to investigate the performance of the ABSOLUTE™ .035 Peripheral Self-Expanding Stent System (ABSOLUTE™ Stent) in preventing restenosis of occluded or stenotic superficial femoral or proximal popliteal arteries. Follow up at 30, 180, 270, 365 days and 2 years. | Device | 1 |
Primary outcome
Restenosis rate (diameter stenosis ≥ 50% as determined by Duplex ultrasound).
Time frame: At 180 days
8 secondary outcomes
Clinically driven target lesion revascularization
Time frame: at 12 and 24 month follow-up
Target lesion primary, primary assisted and secondary patency rates
Time frame: at 6, 12 and 24 month follow-up
Major complications
Time frame: at 1, 6, 12 and 24 month follow-up
Angiographic binary restenosis rate in a subset of patients
Time frame: at 9 month follow-up
Device and procedure success
Time frame: Acute
Vascular and bleeding complications (local and puncture site)
Time frame: 1, 6, 12, 24 months
Stent fracture determined by biplane X-ray
Time frame: at 12 month follow-up
Restenosis rate at 365 days, and 2 years (diameter stenosis ≥ 50% as determined by Duplex ultrasound)
Time frame: 365 days and 2 years
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 24 Feb 2010.
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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.
Thomas Zeller, M.D. principal investigator
Herzzentrum Bad Krozingen, Germany
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent in people with Peripheral Vascular Diseases, run by Abbott Medical Devices at 13 sites in 7 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 9 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 24 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Italy, Austria, France, Belgium and 2 more countries. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Restenosis rate (diameter stenosis ≥ 50% as determined by Duplex ultrasound). (time frame: At 180 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 24 Feb 2010.