An observational study in Arterial Occlusive Diseases, Atherosclerosis and Vascular Diseases, sponsored by Boston Scientific Corporation. Completed at 23 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Boston Scientific Corporation · Observational
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.
1,517 studies on the registry are indexed under Atherosclerosis; 224 are open to participants now.
This study's enrollment of 291 is above the median of 250 across 527 observational studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →Boston Scientific Corporation is the lead sponsor of 528 studies on the registry; 40 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Compared within Atherosclerosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Arterial Occlusive Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The Intended population for the REGAL study are 'real world'-patients with symptomatic de-novo, restenotic, or (re)occluded lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameter (RVD) ranging from 4.0-6.0 mm, suitable for endovascular treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Peripheral stenting
Device: Peripheral stenting
stent implantation during the index procedure
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
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.
Time frame: 12 and 24 months
Number of Participants With Hemodynamic Improvement
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.
Time frame: 12 and 24 months
Health Care Utilization
Changes in healthcare utilization over time
Time frame: 1, 6, 12 and 24 months
Number of Participants With Technical Success of the Stenting Procedure
Number of participants that successfully received Eluvia stent. Technical success defined as implanted and achieving residual angiographic stenosis no greater than 30% assessed visually.
Time frame: During stenting procedure
Number of Participants With Procedural Success of the Stenting Procedure
Number of participants with successful procedures. Procedural success defined as technical success with no major adverse events (MAEs) noted within 24 hours of the stenting procedure.
Time frame: within 24 hours of stenting procedure
Number of Participants With a Major Adverse Event (MAE)
Number of participants with Clinical Events Committee (CEC) adjudicated MAEs at 12- and 24-Months cumulatively. The MAEs are defined as all causes of death, target limb major amputation and/or Target Lesion Revascularization rate. A participant can be present in more than one sub-category.
Time frame: 12 and 24 months
Percentage of Participants With Primary Patency at 12- and 24-Months Post Procedure
The numbers represent the percentage of patients that were event free at 12 and 24 months (i.e. didn't have a TLR).
Time frame: 12 and 24 months
Number of Participants With a Clinically-driven Target Lesion Revascularization (TLR)
The cumulative number of participants that received a clinically-driven target lesion revascularization after the stenting procedure.
Time frame: 12 and 24 months
Number of Participants With a Clinically-driven Target Vessel Revascularization (TVR)
The cumulative number of participants that received a clinically-driven target vessel revascularization after the stenting procedure.
Time frame: 12 and 24 months
Participant Distribution on the Rutherford Classification at Baseline, 12-, and 24- Month
Rutherford Classification: 0\. Asymptomatic - Normal Treadmill /stress test 1. Mild claudication - Completes treadmill exercise; ankle pressure (AP) after exercise \<50mm Hg, but \>25 mm Hg less than blood pressure (BP) 2. Moderate claudication - Between categories 1 and 3 3. Severe claudication - Cannot complete treadmill exercise and AP after exercise \<50 mm Hg 4. Ischemic rest pain - Resting AP \<40 mm Hg, flat or barely pulsatile ankle or metatarsal pulse volume recording (PVR); toe pressure (TP) \<30 mm Hg 5. Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal edema - Resting AP \<60 mm Hg, ankle or metatarsal (MT) PVR flat or barely pulsatile; TP \<40 mm Hg 6. Major tissue loss-extending above MT level - Same as Category 5
Time frame: Baseline, 12 and 24 months
| Milestone | ELUVIA Drug-Eluting Vascular Stent System |
|---|---|
| Started | 291 |
| Completed | 216 |
| Not completed | 75 |
| Withdrew: Withdrawal by subject | 7 |
| Withdrew: Adverse event | 1 |
| Withdrew: Physician decision | 1 |
| Withdrew: Lost to follow-up | 18 |
| Withdrew: Visit missed | 19 |
| Withdrew: Death | 28 |
| Withdrew: Site indicated follow up was not possible | 1 |
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.
| score on a scale | ELUVIA Drug-Eluting Vascular Stent System |
|---|---|
| Baseline Index Value | 0.7 ± 0.2 |
| 12-month Index Value | 0.9 ± .02 |
| 24-month Index Value | 0.8 ± 0.2 |
| Baseline - Visual Analogue Scale | 60.9 ± 18.8 |
| 12-month - Visual Analogue Scale | 73.4 ± 16.8 |
| 24-month - Visual Analogue Scale | 72.0 ± 17.2 |
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.
| Participants | ELUVIA Drug-Eluting Vascular Stent System |
|---|---|
| 12 Month - Distance Score - Number of Participants Improved | 166 |
| 24 Month - Distance Score - Number of Participants Improved | 156 |
| 12 Month - Speed Score - Number of Participants Improved | 158 |
| 24 Month - Speed Score - Number of Participants Improved | 140 |
| 12 Month - Stair Climbing Score - Number of Participants Improved | 132 |
| 24 Month - Stair Climbing Score - Number of Participants Improved | 116 |
| 12 Month - Peripheral Arterial Disease Specific Question Score - Number of Participants Improved | 170 |
| 24 Month - Peripheral Arterial Disease Specific Question Score - Number of Participants Improved | 153 |
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.
| Participants | ELUVIA Drug-Eluting Vascular Stent System |
|---|---|
| 12 Month - Primary Sustained Clinical Improvement | 187 |
| 24 Month - Primary Sustained Clinical Improvement | 165 |
| 12 Month - Secondary Sustained Clinical Improvement | 203 |
| 24 Month - Secondary Sustained Clinical Improvement | 185 |
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.
| Participants | ELUVIA Drug-Eluting Vascular Stent System |
|---|---|
| 12 Month - Hemodynamic Improvement | 137 |
| 24 Month - Hemodynamic Improvement | 102 |
| 12 Month - Hemodynamic Improvement (Including TLR) | 146 |
| 24 Month - Hemodynamic Improvement (Including TLR) | 114 |
Changes in healthcare utilization over time
Results for this outcome have not been posted.
Number of participants that successfully received Eluvia stent. Technical success defined as implanted and achieving residual angiographic stenosis no greater than 30% assessed visually.
| Participants | ELUVIA Drug-Eluting Vascular Stent System |
|---|---|
| Number of Participants With Technical Success of the Stenting Procedure | 288 |
Number of participants with successful procedures. Procedural success defined as technical success with no major adverse events (MAEs) noted within 24 hours of the stenting procedure.
| Participants | ELUVIA Drug-Eluting Vascular Stent System |
|---|---|
| Number of Participants With Procedural Success of the Stenting Procedure | 288 |
Number of participants with Clinical Events Committee (CEC) adjudicated MAEs at 12- and 24-Months cumulatively. The MAEs are defined as all causes of death, target limb major amputation and/or Target Lesion Revascularization rate. A participant can be present in more than one sub-category.
| Participants | ELUVIA Drug-Eluting Vascular Stent System |
|---|---|
| 12 Month - All Deaths | 23 |
| 12 Month - Major Amputation | 6 |
| 12 Month - Target Lesion Revascularization | 25 |
| 24 Month - All Deaths | 28 |
| 24 Month - Major Amputation | 6 |
| 24 Month - Target Lesion Revascularization | 30 |
The numbers represent the percentage of patients that were event free at 12 and 24 months (i.e. didn't have a TLR).
| Participants | ELUVIA Drug-Eluting Vascular Stent System |
|---|---|
| 12 Month - Primary Patency | 268 |
| 24 Month - Primary Patency | 251 |
The cumulative number of participants that received a clinically-driven target lesion revascularization after the stenting procedure.
| Participants | ELUVIA Drug-Eluting Vascular Stent System |
|---|---|
| 12 Month - Clinical Driven TLR | 24 |
| 24 Month - Clinical Driven TLR | 29 |
The cumulative number of participants that received a clinically-driven target vessel revascularization after the stenting procedure.
| Participants | ELUVIA Drug-Eluting Vascular Stent System |
|---|---|
| 12 Month - Clinically Driven TVR | 29 |
| 24 Month - Clinically Driven TVR | 35 |
Rutherford Classification: 0\. Asymptomatic - Normal Treadmill /stress test 1. Mild claudication - Completes treadmill exercise; ankle pressure (AP) after exercise \<50mm Hg, but \>25 mm Hg less than blood pressure (BP) 2. Moderate claudication - Between categories 1 and 3 3. Severe claudication - Cannot complete treadmill exercise and AP after exercise \<50 mm Hg 4. Ischemic rest pain - Resting AP \<40 mm Hg, flat or barely pulsatile ankle or metatarsal pulse volume recording (PVR); toe pressure (TP) \<30 mm Hg 5. Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal edema - Resting AP \<60 mm Hg, ankle or metatarsal (MT) PVR flat or barely pulsatile; TP \<40 mm Hg 6. Major tissue loss-extending above MT level - Same as Category 5
| Participants | ELUVIA Drug-Eluting Vascular Stent System |
|---|---|
| Baseline - Category 0: Asymptomatic | 2 |
| Baseline - Category 1: Mild claudication | 2 |
| Baseline - Category 2: Moderate claudication | 70 |
| Baseline - Category 3: Severe claudication | 108 |
| Baseline - Category 4: Ischemic rest pain | 27 |
| Baseline - Category 5: Minor tissue loss | 71 |
| Baseline - Category 6: Major tissue loss | 10 |
| 12 Month - Category 0: Asymptomatic | 149 |
| 12 Month - Category 1: Mild claudication | 33 |
| 12 Month - Category 2: Moderate claudication | 27 |
| 12 Month - Category 3: Severe claudication | 5 |
| 12 Month - Category 4: Ischemic rest pain | 2 |
| 12 Month - Category 5: Minor tissue loss | 6 |
| 12 Month - Category 6: Major tissue loss | 3 |
| 24 Month - Category 0: Asymptomatic | 139 |
| 24 Month - Category 1: Mild claudication | 30 |
| 24 Month - Category 2: Moderate claudication | 19 |
| 24 Month - Category 3: Severe claudication | 9 |
| 24 Month - Category 4: Ischemic rest pain | 1 |
| 24 Month - Category 5: Minor tissue loss | 4 |
| 24 Month - Category 6: Major tissue loss | 1 |
Collected over Major Adverse Events (all cause death, major amputation, and TLR) were collected through 24-months of follow-up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ELUVIA Drug-Eluting Vascular Stent System | 28/291 (9.6%) | 87/291 (29.9%) | 22/291 (7.6%) |
| Event | ELUVIA Drug-Eluting Vascular Stent System |
|---|---|
| Vascular Stent ThrombosisGeneral disorders | 10/291 |
| Peripheral Artery StenosisVascular disorders | 8/291 |
| Vascular Stent OcclusionGeneral disorders | 8/291 |
| Vascular Stent StenosisGeneral disorders | 8/291 |
| Vascular PseudoaneurysmVascular disorders | 7/291 |
| Death (Unknown)General disorders | 6/291 |
| Extremity NecrosisVascular disorders | 6/291 |
| Peripheral Artery OcclusionVascular disorders | 5/291 |
| Toe AmputationSurgical and medical procedures | 5/291 |
| Vascular DisordersVascular disorders | 4/291 |
| Event | ELUVIA Drug-Eluting Vascular Stent System |
|---|---|
| Vascular Stent StenosisGeneral disorders | 6/291 |
| Vascular Stent ThrombosisGeneral disorders | 4/291 |
| Artery DissectionVascular disorders | 3/291 |
| Toe AmputationSurgical and medical procedures | 3/291 |
| Vascular Stent OcclusionGeneral disorders | 3/291 |
| HaematomaVascular disorders | 1/291 |
| Extremity NecrosisVascular disorders | 1/291 |
| Vascular PseudoaneurysmVascular disorders | 1/291 |
| Age, Continuous(years) | ELUVIA Drug-Eluting Vascular Stent System |
|---|---|
| Mean | 69.7 ± 9.6 |
| Sex: Female, Male(Participants) | ELUVIA Drug-Eluting Vascular Stent System |
|---|---|
| Female | 50 |
| Male | 241 |
| Race/Ethnicity, Customized(Participants) | ELUVIA Drug-Eluting Vascular Stent System |
|---|---|
| American Indian or Alaskan native | 1 |
| Asian | 0 |
| Black of African heritage | 0 |
| Caucasian | 275 |
| Hispanic or Latino | 7 |
| Native Hawaiian or other Pacific Islander | 0 |
| Other | 0 |
| Not disclosed | 8 |
| Region of Enrollment(participants) | ELUVIA Drug-Eluting Vascular Stent System |
|---|---|
| Belgium | 94 |
| Italy | 90 |
| France | 14 |
| Spain | 93 |
| Smoking Status(Participants) | ELUVIA Drug-Eluting Vascular Stent System |
|---|---|
| Current | 98 |
| Never | 38 |
| Previous | 139 |
| Unknown | 16 |
| Current Diabetes Mellitus(Participants) | ELUVIA Drug-Eluting Vascular Stent System |
|---|---|
| Count of participants | 141 |
| History of Hyperlipidemia requiring medication(Participants) | ELUVIA Drug-Eluting Vascular Stent System |
|---|---|
| Count of participants | 197 |
| History of Hypertension requiring medication(Participants) | ELUVIA Drug-Eluting Vascular Stent System |
|---|---|
| Count of participants | 229 |
9 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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