The DESappear Study: Drug Eluting Scaffold

NCT02869087 | Completed DMC

• 1 other identifier: ELX CL 1501
• Study Type: interventional
• Target: 21
• Locations: 4 countries
• Sites: 11

Brief Summary

The aim of this study is to prospectively collect information to evaluate the safety and performance of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral scaffold system for the treatment of symptomatic primary atherosclerotic stenoses and occlusions of the superficial femoral artery (SFA).

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (2)

• Freedom from composite of perioperative death < 30 days and freedom from major adverse limb events (MALE) defined as the occurrence of major amputation, thrombectomy, thrombolysis or major open surgical revascularization

  Primary Safety Endpoint

  6 months

• Primary Patency defined as the freedom from restenosis (>50% diameter reduction defined by Duplex Ultrasound) or clinically driven target lesion revascularization through 6 months

  Primary Effectiveness Endpoint

  6 months

Secondary Outcomes (20)

• Freedom from composite of perioperative death within 30 days and freedom from major adverse limb events (MALE) defined as the occurrence of major amputation, thrombectomy, thrombolysis or major open surgical revascularization.

  12 months

• Freedom from the composite of target lesion (TL) occlusion, reintervention or restenosis defined as a >50% diameter reduction in the target lesion, as confirmed by Duplex Ultrasound or angiography

  12 months

• All cause mortality

  12 months

• Technical Success defined as the successful delivery and deployment of the device assessed by angiography at the conclusion of the procedure

  Post Procedure- Procedure may take up to 2 hours

• Technical Success defined as no implantation of metallic stent assessed by angiography at the conclusion of the procedure

  Post Procedure, procedure may take up to 2 hours

Study Arms (1)

Single Group

EXPERIMENTAL

Single Arm study, study subjects are assigned to treatment with the Akesys Prava Scaffold

Device: Akesys Prava Scaffold

Interventions

Akesys Prava Scaffold DEVICE

Implantation of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral Scaffold System

Single Group

Eligibility Criteria

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

You may qualify if:

• Subject is ≥18 years of age.
• Subject has been informed of the nature of the study, agrees to its provisions, is able to provide informed consent, and agrees to undergo all protocol-required follow up examinations and requirements.
• Subject's life expectancy is at least 1 year.
• Subject is diagnosed as having symptomatic claudication (Rutherford-Becker Clinical Category 2-4).
• For females of childbearing potential, a negative pregnancy test within 14 days before index procedure is required
• Subject is able to take a P2Y12 receptor antagonist (e.g. clopidogrel, ticagrelor, prasugrel or ticagrelor) and acetylsalicylic acid (aspirin).
• A single, de novo native disease segment of the SFA
• Proximal margin of target lesion is ≥1 cm distal to the common femoral artery bifurcation; distal margin of target lesion is within the SFA.
• Vessel diameter from ≥5.0 mm to ≤6.0 mm evaluated by on-line quantitative vascular angiography (QVA) after pre-dilatation per core laboratory guidelines.
• Target lesion diameter reduction ≥50%
• Target lesion length ≤53 mm
• Patent inflow artery free from significant lesion (≥50% diameter reduction;
• Patent distal popliteal artery free from significant lesion (≥50%) with angiographic demonstration of at least one fully patent distal outflow artery (anterior tibial, posterior tibial, or peroneal) to its terminus.

You may not qualify if:

• Previous bypass surgery or stenting at the TL;
• Percutaneous or open surgical revascularization of the contralateral iliac or infrainguinal arteries ≤30 days prior to the planned index procedure. Iliac artery lesions may be treated during the index procedure if necessary for approach to the TL;
• Failure to successfully cross the target lesion with a guide wire;
• Subject has a known abdominal aortic aneurysm \>4 cm in diameter, a known iliac artery aneurysm \>3 cm in diameter, or history of open surgical abdominal aortic or iliac revascularization.
• Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm;
• Subject is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus);
• Acute limb ischemia;
• History of a bleeding diathesis;
• History of a hypercoagulability syndrome;
• Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3; a WBC \<3,000 cells/mm3; or hemoglobin \<10.0 g/dL;
• Acute or chronic renal dysfunction (creatinine \>2.5 mg/dl or \>176 μmol/L), or on chronic hemodialysis;
• Severe liver impairment as defined by total bilirubin ≥3 mg/dl or two times increase over the normal level of SGOT/AST or SGPT/ALT;
• Known allergies to the following: aspirin, clopidogrel, prasugrel, ticagrelor, or heparin, contrast agent (that cannot be adequately premedicated), or drugs similar to sirolimus (i.e. tacrolimus, everolimus, zotarolimus) or other macrolides;
• Subject requires planned procedure within 30 days that would necessitate the discontinuation of clopidogrel, prasugrel, or ticagrelor;
• Subject is on chronic Coumadin therapy

Sponsors & Collaborators

• Elixir Medical Corporation: lead
• Syntactx: collaborator
• Massachusetts General Hospital: collaborator
• Genae: collaborator

Study Sites (11)

LKH University Hospital Graz

Graz, Styria, A8036, Austria

Location

Hanusch Hospital

Vienna, 1140, Austria

Location

AZ Sint Blasius, Dendermonde

Dendermonde, Brussels Capital, Belgium

Location

Heilig Hart Hospital

Tienen, Belgium

Location

Bonifatius Hospital

Lingen, Lower Saxony, 49808, Germany

Location

Klinikum Arnsberg

Arnsberg, North Rhine-Westphalia, 59759, Germany

Location

Heart Center Bad Krozingen

Freiburg im Breisgau, Germany

Location

Universitätsklinikum Leipzig AöR,

Leipzig, Germany

Location

St Franziskus Hospital

Münster, Germany

Location

Auckland City Hospital

Auckland, New Zealand

Location

Wellington Hospital

Wellington, New Zealand

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marc Bosiers, Doctor

  AZ Sint-Blasius Dendermonde

  PRINCIPAL INVESTIGATOR

• Dierk Scheinert, Doctor

  Universitätsklinikum Leipzig

  PRINCIPAL INVESTIGATOR

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: May 31, 2016
• First Posted: August 16, 2016
• Study Start: October 10, 2016
• Primary Completion: August 28, 2018
• Study Completion: April 30, 2021
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2); DE (5); AU (2); BE (2)