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

Atherosclerosis Clinical Trial

— REGAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03037411
• Other study ID #: S2346
• Status: Completed
• Start date: December 13, 2016
• Est. completion date: March 24, 2022

Study information

• Verified date: November 2022
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: March 24, 2022
• Est. primary completion date: March 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Arteriosclerosis
• Atherosclerosis
• Vascular Diseases

Intervention

Device:
• Peripheral stenting
stent implantation during the index procedure

Locations

Country	Name	City	State
Austria	Medizinische Universität Graz	Graz
Belgium	ZOL Genk	Genk	Limburg
Belgium	CHU Sart Tilman	Liège
Belgium	Regionaal Ziekenhuis Heilig Hart Tienen	Tienen	Vlaams-Brabant
France	Centre Hospitalier Universitaire Grenoble-Alpes	Grenoble
France	Clinique Parly II	Le Chesnay
Italy	ASL Asti	Asti
Italy	Policlinico Vittorio Emanuele	Catania
Italy	Policlinico di Monza	Monza
Italy	L'Azienda sanitaira ASL Roma 1	Roma
Italy	Policlinico Umberto I	Roma
Italy	IRCCS Policlinico San Donato	San Donato Milanese
Italy	Hospital Azienda Ospedaliera Universitaria Senese	Siena
Spain	Hospital Universitario de Burgos	Burgos
Spain	Hospital San Pedro de Alcántara	Cáceres
Spain	Hosp. Puerta del Mar	Cadiz
Spain	Hosp . Universitario de Guadalajara	Guadalajara
Spain	Hosp. Ntra Sra. del Rosario	Madrid
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hosp. Complejo Hosp Universitario (CHUO)	Ourense
Spain	Hospital de Montecelo (Pontevedra EOXI)	Pontevedra
Spain	Hospital Parc Tauli	Sabadell
Spain	Foundation for the Aragonese Healthcare Research Institute	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Technical success of the 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	During stenting procedure
Other	Procedural success of the stenting procedure	Procedural success defined as technical success with no MAEs noted within 24 hours of the stenting procedure	within 24 hours of stenting procedure
Other	Adverse Event and Major Adverse Event (MAE) rate	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	1, 6, 12 and 24 months
Other	Primary patency	Primary patency of target lesion assessed by duplex ultrasound as adjudicated by an independent core laboratory	6, 12 and 24 months
Other	Clinically-driven Target Lesion Revascularization (TLR) Rate	Target Lesion Revascularization is defined as any surgical or percutaneous intervention to the target lesion(s) after the stenting procedure	1, 6, 12 and 24 months
Other	Clinically-driven Target Vessel Revascularization (TVR) Rate	Target Vessel Revascularization is defined as any surgical or percutaneous intervention to the target vessel after the stenting procedure	1, 6, 12 and 24 months
Other	Distribution of Rutherford Classification	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	1, 6, 12 and 24 months
Primary	Health care costs	Health care costs at index procedure and changes in health care costs from baseline	Index Procedure, 1, 6, 12 and 24 months
Secondary	Quality of Life Improvement	Change in EQ-5D-5L™ from baseline	1, 6, 12 and 24 months
Secondary	Walking Improvement	Change in Walking Impairment Questionnaire (WIQ) from baseline	1, 6, 12 and 24 months
Secondary	Rate of Primary and Secondary Sustained Clinical Improvement	Changes in Rutherford Classification from baseline	1, 6, 12 and 24 months
Secondary	Rate of Hemodynamic Improvement	Changes in in Ankle-Brachial Index (ABI) from baseline	1, 6, 12 and 24 months
Secondary	Health care utilization	Changes in healthcare utilization over time	1, 6, 12 and 24 months