Arterial Occlusive Diseases, Arteriosclerosis, Atherosclerosis, Vascular Diseases
Conditions
Keywords
Atherosclerosis, Superficial Femoral Artery (SFA), Proximal Popliteal Artery (PPA), Stenting, Paclitaxel, Health Economics
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPeripheral stenting
stent implantation during the index procedure
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Quality-of-Life Changes Via EuroQol 5 Dimension (EQ-5D) Questionnaire. | Baseline,12 and 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Improvement on the Walking Impairment Questionnaire | 12 and 24 months | 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. |
| Number of Participants With Improved Rutherford Classification Indicating Rate of Primary and Secondary Sustained Clinical Improvement | 12 and 24 months | 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. |
| Number of Participants With Hemodynamic Improvement | 12 and 24 months | Number of participants with improvement in Ankle-Brachial Index (ABI) at 12- and 24-Months compared to baseline. Hemodynamic Improvement is defined as an increase in ABI of \>= 0.10 or to an ABI \>= 0.90 as compared to baseline without the need for repeat TLR. The ABI measures the arterial pressure in the leg compared to the arterial pressure in the arm. The higher the value, the better the blood flow. Improvement is defined as an increase in the ABI by greater than or equal to 0.10 compared with baseline or to an ABI greater than or equal to 0.90. The percentages in the table represent the patients that demonstrated an improvement in their ABI from baseline to 12 months and baseline to 24-months. |
| Health Care Utilization | 1, 6, 12 and 24 months | Changes in healthcare utilization over time |
Countries
Austria, Belgium, France, Italy, Spain
Contacts
PRINCIPAL_INVESTIGATORCarlo Setacci
Policlinico Le Scotte, Siena
Participant flow
Pre-assignment details
291 participants were enrolled and implanted with the Eluvia Stent
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 69.7 years STANDARD_DEVIATION 9.6 |
| Cardiac history Historic of coronary artery disease | 90 Participants |
| Cardiac history History of congestive heart failure | 22 Participants |
| Cardiac history History of Myocardial infarction (MI) | 61 Participants |
| Chronic Total Occlusion | 145 Participants |
| Current Anginal Status None | 265 Participants |
| Current Anginal Status Stable angina | 6 Participants |
| Current Anginal Status Unknown | 17 Participants |
| Current Anginal Status Unstable angina | 3 Participants |
| Current Diabetes Mellitus | 141 Participants |
| History of Chronic Obstructive Pulmonary Disease | 45 Participants |
| History of Endovascular Interventions in Target Vessel | 43 Participants |
| History of Hyperlipidemia requiring medication | 197 Participants |
| History of Hypertension requiring medication | 229 Participants |
| History of Peripheral Vascular Disease | 57 Participants |
| History of Renal Insufficiency | 44 Participants |
| New York Heat Assoc. (NHYA) Classification Class I | 4 Participants |
| New York Heat Assoc. (NHYA) Classification Class II | 7 Participants |
| New York Heat Assoc. (NHYA) Classification Class III | 0 Participants |
| New York Heat Assoc. (NHYA) Classification Class IV | 2 Participants |
| New York Heat Assoc. (NHYA) Classification Unknown | 9 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan native | 1 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black of African heritage | 0 Participants |
| Race/Ethnicity, Customized Caucasian | 275 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 7 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Not disclosed | 8 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Region of Enrollment Belgium | 94 participants |
| Region of Enrollment France | 14 participants |
| Region of Enrollment Italy | 90 participants |
| Region of Enrollment Spain | 93 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 241 Participants |
| Smoking Status Current | 98 Participants |
| Smoking Status Never | 38 Participants |
| Smoking Status Previous | 139 Participants |
| Smoking Status Unknown | 16 Participants |
| Target Lesion Length | 98.4 mm STANDARD_DEVIATION 73.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 28 / 291 |
| other Total, other adverse events | 22 / 291 |
| serious Total, serious adverse events | 87 / 291 |
Outcome results
None listed