Belgian Prospective Multicentre Registry on the Performance of the Smart Stent in the Superficial Femoral Artery According to the New Tasc II-classification

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

NA

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-12-31

Brief Summary

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

This is a Belgian prospective multicentre registry on the performance of the Smart stent in the superficial femoral artery according to the new tasc II-classification.

Related Clinical Trials

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

Belgian Prospective Multicentre Registry to Evaluate Safety and Performance of the Optimed Stent in the Superficial Femoral Artery

NCT01499342

Peripheral Arterial Disease

COMPLETED

Remedy, Biodegradable Peripheral Stent Registry

NCT01420120

Peripheral Arterial Disease

COMPLETED

BeSmooth Study, Investigating the BeSmooth Peripheral Stent System for the Treatment of Iliac Lesions

NCT02690051

Peripheral Arterial Disease

COMPLETED PHASE4

Clinical Trial Investigating the Efficacy of the Supera Peripheral Stent System for the Treatment of the Common Femoral Artery

NCT02804113

Peripheral Arterial Disease

COMPLETED NA

Prospective, Single-arm, Multi Centre Observations Ultimaster Des Registry

NCT02188355

Coronary Artery Disease

UNKNOWN

Detailed Description

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

Conditions

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

Peripheral Vascular Disease

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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

Smart Stent in the Superficial Femoral Artery .

Group Type EXPERIMENTAL

Registry

Intervention Type PROCEDURE

A Registry will be used.

Interventions

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

Registry

A Registry will be used.

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* Stenosis (\> 75%) or occlusion of the superficial femoral artery (lesion up to 3 cm distal to Hunter's canal)
* New TASC (2007) A, B, or C lesions
* Vessel diameter between 4.5 and 6.5 cm
* Debilitating claudication or critical limb ischemia (Rutherford 2 to 5)
* At least 1 outflow vessel down to the ankle
* Signed informed consent
* \> Age 50, life expectancy \> 1 year
* Capable of concluding the necessary follow-up visits

Exclusion Criteria

* Refusal to participate in the study
* Acute ischemia
* Inflow lesions \> 50%, not successfully corrected before the procedure
* Combination with other treatment with the exception of treatment to improve the inflow

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No