Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study

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

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-11-04

Brief Summary

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

The objective of the study is to assess the incidence of safety outcomes in patients treated with Pipeline™ Flex embolization device with Shield Technology™.

Related Clinical Trials

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

PMCF Study for Peripheral Arteries Above the Knee (ATK)

NCT05312580

Peripheral Arterial Disease Femoropopliteal Stenosis Angiopathy, Peripheral

COMPLETED

Post-market Registry Study on the Safety and Efficacy of ZENFLEX Pro™ Peripheral Drug-eluting Stent System for Femoropopliteal Artery Lesions

NCT07122167

Peripheral Arterial Disease

RECRUITING NA

Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries

NCT01412541

Femoral Artery Stenosis Popliteal Artery Stenosis Femoral Artery Occlusion +1 more

COMPLETED NA

Evaluation of Efficacy and Safety of the FlexStent Self-Expanding Stent System

NCT01071460

Efficacy of the Study Device

COMPLETED PHASE3

Paclitaxel-eluting Balloon Angioplasty With Provisional Use of Nitinol Stent Versus Systematic Implantation of Paclitaxel-eluting Stent for the Treatment of Femoropopliteal de Novo Lesions

NCT01969630

Peripheral Artery Disease

UNKNOWN PHASE4

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.

Aneurysm

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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

Inclusion Criteria

1. Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements.
2. Age 18-80 years.
3. Subject has already been selected for flow diversion therapy as the appropriate treatment.
4. Subject has an unruptured target intracranial aneurysm (IA).
5. Subject has a target IA located in the anterior or posterior circulation.

Exclusion Criteria

1. Major surgery in the past 30 days.
2. Any known contraindication to treatment with the Pipeline™ Flex embolization device with Shield Technology™ per Instructions for Use.
3. Pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No