FORMAT 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

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2017-07-17

Brief Summary

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

The FORMAT Clinical Study is a clinical trial to evaluate the safety and effectiveness of the Formula™ 535 Iliac Balloon-Expandable Stent in treatment of symptomatic vascular disease of the iliac arteries.

Related Clinical Trials

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

DURABILITY™ Iliac Study

NCT01400919

Peripheral Arterial Disease Claudication

COMPLETED NA

A Study of the Gore VIABAHN BX for Treatment of Occlusive Disease in the Iliac Arteries.

NCT02080871

Peripheral Arterial Disease

COMPLETED NA

REFORM Clinical Study: Treatment of Renal Artery Stenosis With the Formula Balloon-Expandable Stent

NCT00631540

Renal Artery Stenosis

COMPLETED NA

Safety and Efficacy of Express LD to Treat Stenosed or Occlusive Atherosclerotic Disease in Iliac Arteries

NCT00352222

Arterial Occlusive Disease Intermittent Claudication Atherosclerotic Disease +1 more

COMPLETED PHASE3

VISIBILITY™ Iliac Study

NCT01402700

Peripheral Arterial Disease Claudication

COMPLETED NA

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.

Symptomatic Vascular Disease of the Iliac Arteries

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

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Stent

Group Type EXPERIMENTAL

Formula™ 535 Iliac Balloon-Expandable Stent

Intervention Type DEVICE

Treatment of symptomatic vascular disease of the iliac arteries

Interventions

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

Formula™ 535 Iliac Balloon-Expandable Stent

Treatment of symptomatic vascular disease of the iliac arteries

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Up to two documented common or external iliac artery lesions (one on each side), with \>50% diameter stenosis, suitable for stenting
* iliac artery reference vessel diameter of 5-10 mm
* Rutherford Category 1, 2, 3, or 4.

Exclusion Criteria

* Less than 18 years of age
* lesion site \<10 or \>100 mm in length
* external iliac artery lesion visually estimated to be 100% occluded
* presence of infrarenal aortic aneurysm \>4 cm (treated or untreated)
* presence of any aneurysm (treated or untreated) within target vessel
* significant stenosis (\>50%) or occlusion of inflow tract (infrarenal aortic lesions) not successfully treated before this procedure (success is measured as \< 30% residual stenosis)
* absence of at least one patent runoff vessel with ≤ 50% stenosis throughout its course (i.e., confirmed in-line patency to the level of the foot)
* angiographically evident thrombus within the target vessel (treated or untreated)
* lesion is in an iliac artery that has been previously stented

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No