A Real World Evaluation of the ELUVIA Stent in Subjects With Lesions Located in the Femoropopliteal Arteries

Boston Scientific Corporation291 enrolled

Overview

The REGAL study is a European, prospective, multi-center Post-Market Clinical Follow-up (PMCF) trial providing additional data including health economics data to support the use of the ELUVIA stent in the treatment of lesions located in the femoropopliteal arteries.

A European, prospective, multi-center Post-Market Clinical Follow-up (PMCF) trial providing additional data including health economics data to support the use of the ELUVIA stent in the treatment of lesions located in the femoropopliteal arteries. The objective of the study is to collect additional data including health economics data to support the use of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions.

Study Type

OBSERVATIONAL

Enrollment

291

Conditions

Arterial Occlusive Diseases Atherosclerosis Vascular Diseases Arteriosclerosis

Interventions

Peripheral stentingDEVICE

stent implantation during the index procedure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects age 18 and older 2. Subject is willing and able to provide written consent before any study-specific test or procedure is performed and agrees to attend all follow-up visits 3. De novo, restenotic or (re)occluded lesions in the native femoro-popliteal arteries, with reference vessel diameter (RVD) ranging from 4.0-6.0 mm, suitable for endovascular treatment Exclusion Criteria: 1. Subject is pregnant or planning to become pregnant during the course of the study 2. Life expectancy of less than 1 year (which is defined as documented life expectancy less than 12 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the clinical follow-up, limit the subject's compliance with the standard of care follow-up, or impact the scientific integrity of the trial) 3. Known allergy to the ELUVIA stent system or any of its components, concomitant medication, contrast agents (that cannot be medically managed) 4. Subject enrolled in an investigational study that has not reached primary endpoint at the time of enrollment or that clinically interferes with the current study assessments (Note: studies requiring extended follow-up for products that were investigational, but have become commercially available since then are not considered investigational studies)

Locations (23)

Medizinische Universität Graz

Graz, Austria

ZOL Genk

Genk, Limburg, Belgium

Outcomes

Primary Outcomes

Participant Quality-of-Life Changes Via EuroQol 5 Dimension (EQ-5D) Questionnaire.

The EQ-5D assesses five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) of health-related quality of life responses assigned by the participants. The values are anchored at 1 (best) to 0 (worst). The vales for the visual analog score takes values from 100 (best) to 0 (worst). The index value is comparable across the baseline, 12- and 24-Months timepoints.

Time frame: Baseline,12 and 24 months

Secondary Outcomes

Number of Participants With Improvement on the Walking Impairment Questionnaire

Improvement was calculated by comparing the scores from 12- and 24-Months to the baseline scores and presenting the number of participants that showed improvement at 12- and 24-Months. The WIQ measures the improvement as reported by participants in their walking distance, walking speed, stair-climbing ability and improvement in their PAD symptoms pre-procedure (baseline) compared to 12 months and compared to 24 months. The improvement at those time points is measured as percent improvement.

Time frame: 12 and 24 months

Number of Participants With Improved Rutherford Classification Indicating Rate of Primary and Secondary Sustained Clinical Improvement

The Rutherford Classification describes the different stages of peripheral artery disease (PAD) from a score of 0 (no PAD) to 6 (critical limb ischemia with major tissue loss). The percentages represent the percent of participants that had sustained clinical improvement from baseline to 12 months and baseline to 24 months. Sustained clinical improvement means their Rutherford Class improved by one or more categories compared with baseline. Number of participants with improved Rutherford Classification at 12- and 24-Months when compared to baseline. Primary Sustained Clinical Improvement is improvement in Rutherford Classification of one or more categories as compared to baseline without the need for repeat target lesion revascularization (TLR). Secondary Sustained Clinical Improvement is improvement in Rutherford classification of one or more categories as compared to baseline including those participants with repeat TLR.

Data from ClinicalTrials.gov

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