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

Sponsor

Boston Scientific Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT03037411

Collaborator

(none)

291

Enrollment

Locations

63.3

Actual Duration (Months)

12.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arterial Occlusive Diseases Atherosclerosis Vascular Diseases Arteriosclerosis	Device: Peripheral stenting

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.

Study Design

Study Type:

Observational

Actual Enrollment :

291 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Real World Evaluation of the ELUVIA Drug Eluting Stent in All-Comers With Superficial Femoral Artery and Proximal Popliteal Artery Disease

Actual Study Start Date :

Dec 13, 2016

Actual Primary Completion Date :

Mar 24, 2022

Actual Study Completion Date :

Mar 24, 2022

Arms and Interventions

Arm	Intervention/Treatment
ELUVIA stent implantation Peripheral stenting	Device: Peripheral stenting stent implantation during the index procedure

Arm

Intervention/Treatment

ELUVIA stent implantation

Peripheral stenting

Device: Peripheral stenting

stent implantation during the index procedure

Outcome Measures

Primary Outcome Measures

Health care costs [Index Procedure, 1, 6, 12 and 24 months]
Health care costs at index procedure and changes in health care costs from baseline

Secondary Outcome Measures

Quality of Life Improvement [1, 6, 12 and 24 months]
Change in EQ-5D-5L™ from baseline
Walking Improvement [1, 6, 12 and 24 months]
Change in Walking Impairment Questionnaire (WIQ) from baseline
Rate of Primary and Secondary Sustained Clinical Improvement [1, 6, 12 and 24 months]
Changes in Rutherford Classification from baseline
Rate of Hemodynamic Improvement [1, 6, 12 and 24 months]
Changes in in Ankle-Brachial Index (ABI) from baseline
Health care utilization [1, 6, 12 and 24 months]
Changes in healthcare utilization over time

Other Outcome Measures

Technical success of the stenting procedure [During stenting procedure]
Technical success defined as delivery and deployment of the study stent to the target lesion to achieve residual angiographic stenosis no greater than 30% assessed visually
Procedural success of the stenting procedure [within 24 hours of stenting procedure]
Procedural success defined as technical success with no MAEs noted within 24 hours of the stenting procedure
Adverse Event and Major Adverse Event (MAE) rate [1, 6, 12 and 24 months]
Adverse Event rate and MAE rate, defined as all causes of death, target limb major amputation and/or Target Lesion Revascularization rate at each time point
Primary patency [6, 12 and 24 months]
Primary patency of target lesion assessed by duplex ultrasound as adjudicated by an independent core laboratory
Clinically-driven Target Lesion Revascularization (TLR) Rate [1, 6, 12 and 24 months]
Target Lesion Revascularization is defined as any surgical or percutaneous intervention to the target lesion(s) after the stenting procedure
Clinically-driven Target Vessel Revascularization (TVR) Rate [1, 6, 12 and 24 months]
Target Vessel Revascularization is defined as any surgical or percutaneous intervention to the target vessel after the stenting procedure
Distribution of Rutherford Classification [1, 6, 12 and 24 months]
Rutherford Classification: 0 Asymptomatic - Normal Treadmill /stress test Mild claudication - Completes treadmill exercise; ankle pressure (AP) after exercise <50mm Hg, but >25 mm Hg less than BP Moderate claudication - Between categories 1 and 3 Severe claudication - Cannot complete treadmill exercise and AP after exercise <50 mm Hg 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 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 Major tissue loss-extending above MT level - Same as Category 5

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects age 18 and older
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
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:

Subject is pregnant or planning to become pregnant during the course of the study
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)
Known allergy to the ELUVIA stent system or any of its components, concomitant medication, contrast agents (that cannot be medically managed)
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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medizinische Universität Graz	Graz		Austria
2	ZOL Genk	Genk	Limburg	Belgium	3600
3	Regionaal Ziekenhuis Heilig Hart Tienen	Tienen	Vlaams-Brabant	Belgium	3300
4	CHU Sart Tilman	Liège		Belgium
5	Centre Hospitalier Universitaire Grenoble-Alpes	Grenoble		France
6	Clinique Parly II	Le Chesnay		France	78150
7	ASL Asti	Asti		Italy	14100
8	Policlinico Vittorio Emanuele	Catania		Italy
9	Policlinico di Monza	Monza		Italy
10	Policlinico Umberto I	Roma		Italy	00161
11	L'Azienda sanitaira ASL Roma 1	Roma		Italy	00193
12	IRCCS Policlinico San Donato	San Donato Milanese		Italy
13	Hospital Azienda Ospedaliera Universitaria Senese	Siena		Italy	53100
14	Hospital Universitario de Burgos	Burgos		Spain	09006
15	Hosp. Puerta del Mar	Cadiz		Spain
16	Hospital San Pedro de Alcántara	Cáceres		Spain	10004
17	Hosp . Universitario de Guadalajara	Guadalajara		Spain	19002
18	Hosp. Ntra Sra. del Rosario	Madrid		Spain	28006
19	Hospital Clinico San Carlos	Madrid		Spain	28040
20	Hosp. Complejo Hosp Universitario (CHUO)	Ourense		Spain
21	Hospital de Montecelo (Pontevedra EOXI)	Pontevedra		Spain	30071
22	Hospital Parc Tauli	Sabadell		Spain
23	Foundation for the Aragonese Healthcare Research Institute	Zaragoza		Spain	50009