ASSESS Study: Evaluation of ABSOLUTE™ Stent System for Occluded Arteries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2009-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Absolute Pro® MOMENTUM™

NCT01444378

Peripheral Artery Disease Peripheral Vascular Disease

COMPLETED NA

Below Study - Balloonangioplasty or Stents With ReoPro for Prevention of Subacute Reocclusion in Arteries Below the Knee

NCT00163254

Patients Above 18 Years

UNKNOWN PHASE2

Vienna Absolute Trial: Balloon Angioplasty Versus Stenting in the Superficial Femoral Artery

NCT00281060

Atherosclerosis

COMPLETED PHASE4

Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions

NCT04434586

Superficial Femoral Artery Stenosis Claudication Ischemic Leg

RECRUITING NA

Study of Drug Eluting Peripheral Vascular Stent System in Superficial Femoral Artery Stenosis and /or Occlusion

NCT03121430

Peripheral Arterial Disease Superficial Femoral Artery Stenosis Superficial Femoral Artery Occlusion

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Vascular Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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.

Group Type OTHER

ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ABSOLUTE™: Self-Expandable Peripheral Nitinol Stent

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
* 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

Exclusion Criteria

* 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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No