ESPRIT I: A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System

NCT01468974 | Completed Results DMC

• 1 other identifier: 11-113
• Study Type: interventional
• Target: 35
• Locations: 4 countries
• Sites: 8

Brief Summary

The purpose of the ESPRIT I Clinical Investigation is to evaluate the safety and performance of the ESPRIT BVS in subjects with symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.

Conditions

Atherosclerosis; Peripheral Vascular Disease; Claudication

Outcome Measures

Primary Outcomes (3)

• Device Success

  Study device success is defined on a per device basis, the achievement of successful delivery and deployment of the study device(s) at the intended target lesion and successful withdrawal of the delivery catheter.

  On Day 0 (From start of index procedure to end of index procedure)

• Technical Success

  Technical success is defined on a per lesion basis, the attainment of a final residual stenosis of \< 30% at the intended target lesion(s). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as technical success only if the above criteria are met.

  On Day 0 (From start of index procedure to end of index procedure)

• Clinical Success

  Defined on a per subject basis, as the attainment of a final residual stenosis of \< 30% using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications\* within 2 days after the index procedure or at hospital discharge, whichever is sooner. (Note that in the ESPRIT I study, only a single target lesion per subject is permitted to be treated). \*Includes the following: Death; Amputation; Scaffold Thrombosis; Target Lesion Revascularization (by any percutaneous or surgical means); Target Vessel Revascularization (by any percutaneous or surgical means).

  > or = 2 days after the index procedure

Secondary Outcomes (125)

• Number of Participants With Death

  1 month

• Number of Participants With Death

  6 months

• Number of Participants With Death

  1 year

• Number of Participants With Death

  2 years

• Number of Participants With Death

  3 years

Study Arms (1)

ESPRIT BVS

OTHER

Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.

Device: ESPRIT BVS

Interventions

ESPRIT BVS DEVICE

Subjects receiving ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries

ESPRIT BVS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥ 18 and ≤ 80 years of age at the time of signing informed consent.
• Subject is diagnosed as having symptomatic claudication (Rutherford-Becker Clinical Category 1-3).
• For subjects with bilateral lesions, the higher Rutherford-Becker Clinical Category limb will be considered the target extremity to be treated in this trial.
• If both limbs are of the same Rutherford Becker Clinical Category, the target extremity will be selected based on investigator discretion.
• Subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and is able to provide informed consent.
• Subject agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site.
• Female subject of childbearing potential must: have had a negative pregnancy test within 14 days before treatment; not be nursing at the time of the study procedure and agree at time of consent to use birth control during participation in this trial.
• Subject has life expectancy \> 12 months.
• Subject is able to take clopidogrel or prasugrel (or ticlopidine, if the subject cannot take clopidogrel or prasugrel) and acetylsalicylic acid (aspirin).
• Subject must agree not to participate in any other clinical investigation for a period of 12 months following the index procedure. This includes clinical trials of medications and invasive procedures. Questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed.
• A single de novo native disease segment of the superficial femoral (SFA) or common or external iliac arteries of the target extremity located within the following anatomical parameters:
• Iliac
• Proximal margin of target lesion is ≥ 2.5 cm distal to the aortic bifurcation in common iliac artery
• Distal margin of target lesion is ≥ 1.5 cm proximal to the location of inguinal ligament
• SFA

You may not qualify if:

• A platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3; a white blood cell count (WBC) \<3,000 cells/mm3; or hemoglobin \< 10.0 g/dL
• Acute or chronic renal dysfunction (creatinine \> 2.5 mg/dl or \>176μmol/L)
• Severe liver impairment as defined by total bilirubin ≥ 3 mg/dl or two times increase over the normal level of serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT).
• Known allergies to the following: aspirin, clopidogrel, prasugrel or ticlopidine, heparin, contrast agent (that cannot be adequately premedicated), or drugs similar to everolimus (i.e. tacrolimus, sirolimus, zotarolimus) or other macrolides.
• Subject requires planned procedure that would necessitate the discontinuation of clopidogrel, prasugrel or ticlopidine.
• Subject has had or will require treatment with drug eluting stent (DES) or drug coated balloon (DCB) within 6 months pre- or post-index procedure.
• Subject is unable to walk.
• Subject has undergone any non-iliac percutaneous intervention, e.g. coronary, carotid, \< 30 days prior to the planned index procedure.
• Subject has received, or is on the waiting list for, a organ transplant.
• Subject is on chronic hemodialysis.
• Subject has uncontrolled diabetes mellitus (DM) (HbA1c ≥ 7.0%).
• Subject has had a myocardial infarction (MI) within the previous 30 days of the planned index procedure.
• Subject has had a stroke within the previous 30 days of the planned index procedure and/or has deficits from a prior stroke that limits the subject's ability to walk.
• Subject has unstable angina defined as rest angina with ECG changes.
• Subject has a groin infection, or an acute systemic infection that has not been treated successfully or is currently under treatment.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (8)

Medical University of Vienna

Vienna, Austria

Location

Abbott Vascular International BVBA

Brussels, 0886.537.933, Belgium

Location

Sint-Blasius Hospital

Dendermonde, Belgium

Location

Oost Limburg Ziekenhuis

Genk, Belgium

Location

Gent University Hospital

Ghent, Belgium

Location

Clinique Pasteur

Toulouse, France

Location

Herzzentrum Bad Krozingen

Bad Krozingen, Germany

Location

Park-Krankenhaus Leipzig

Leipzig, Germany

Location

Related Publications (1)

• Lammer J, Bosiers M, Deloose K, Schmidt A, Zeller T, Wolf F, Lansink W, Sauguet A, Vermassen F, Lauwers G, Scheinert D, Popma JJ, McGreevy R, Rapoza R, Schwartz LB, Jaff MR. Bioresorbable Everolimus-Eluting Vascular Scaffold for Patients With Peripheral Artery Disease (ESPRIT I): 2-Year Clinical and Imaging Results. JACC Cardiovasc Interv. 2016 Jun 13;9(11):1178-87. doi: 10.1016/j.jcin.2016.02.051.

  PMID: 27282601 DERIVED

MeSH Terms

Conditions

Atherosclerosis; Peripheral Vascular Diseases; Intermittent Claudication

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Arterial Disease; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nadia bouhdi
• Organization: Abbott Vascular

nadia.bouhdi@av.abbott.com

Study Officials

• Johannes Lammer, Prof. Dr.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2011
• First Posted: November 10, 2011
• Study Start: November 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 4, 2019
• Results First Posted: February 4, 2019

Record last verified: 2018-02

Locations

BE (4); FR (1); AU (1); DE (2)