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The DESappear Study: Drug Eluting Scaffold (DESappear)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02869087
Recruitment Status : Active, not recruiting
First Posted : August 16, 2016
Last Update Posted : April 8, 2020
Sponsor:
Collaborators:
Syntactx
Massachusetts General Hospital
Genae
Information provided by (Responsible Party):
Elixir Medical Corporation

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).

Condition or disease Intervention/treatment Phase
Peripheral Vascular Disease Device: Akesys Prava Scaffold Not Applicable

Detailed Description:

This is a mutli center, prospective ,single arm study enrolling up to 60 patients at up to 12 centers in New Zealand and Europe.

The purpose is to prospectively collect information to evaluate the safety and performance of the Akesys Prava Sirolimus eluting bioresorbable scaffold system in peripheral arterial disease (PAD) Patients will be treated with the investigational device and followed up clinically at 1 month, 6 Months, 12 months, 24 months and 36 months post procedure.

Patients will undergo non-invasive assessments such as Duplex Ultrasound (DUS), Ankle/Brachial Index (ABI) measurements and will complete a Walking Impairment Questionnaire (WIQ) and Quality of Life Questionnaire (VASCUQoL) at each follow up interval.

Data will be collected via electronic data capture (EDC) and reportable Events will be reviewed by a medical monitor and classified using the MedDRA system. The information entered by the research centres will be source data verified (monitored) by an independent Contract Research Organisation (CRO.) A Data Monitoring Committee (DMC) with appropriately qualified members independent of the study will meet to review and adjudicate on events at predetermined intervals, according to the charter.

Primary safety and efficacy endpoints will be evaluated at 6 months There will be no formal hypothesis testing in the study, endpoints will be evaluated with 95% confidence intervals around the observed point estimates. The endpoints will be evaluated with Kaplan-Meier methodology.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DESappear Study: Drug Eluting Scaffold With an Absorbable Platform for Primary Lower Extremity Arterial Revascularization
Actual Study Start Date : October 10, 2016
Actual Primary Completion Date : August 28, 2018
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Lomustine

Arm Intervention/treatment
Experimental: Single Group
Single Arm study, study subjects are assigned to treatment with the Akesys Prava Scaffold
Device: Akesys Prava Scaffold
Implantation of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral Scaffold System




Primary Outcome Measures :
  1. 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 [ Time Frame: 6 months ]
    Primary Safety Endpoint

  2. Primary Patency defined as the freedom from restenosis (>50% diameter reduction defined by Duplex Ultrasound) or clinically driven target lesion revascularization through 6 months [ Time Frame: 6 months ]
    Primary Effectiveness Endpoint


Secondary Outcome Measures :
  1. 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. [ Time Frame: 12 months ]
    Secondary Safety endpoint

  2. 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 [ Time Frame: 12 months ]
    Secondary Effectiveness Endpoint

  3. All cause mortality [ Time Frame: 12 months ]
  4. Technical Success defined as the successful delivery and deployment of the device assessed by angiography at the conclusion of the procedure [ Time Frame: Post Procedure- Procedure may take up to 2 hours ]
    The assessment will be made and evaluated at the conclusion of the index procedure

  5. Technical Success defined as no implantation of metallic stent assessed by angiography at the conclusion of the procedure [ Time Frame: Post Procedure, procedure may take up to 2 hours ]
    the assessment will be made and evaluated at the conclusion of the Index procedure

  6. Technical Success defined as < 30%residual stenosis after successful implantation of the scaffold assessed by angiography at the conclusion of the procedure [ Time Frame: Post Procedure, procedure may take up to 2 hours ]
    The assessment will be made and evaluated at the conclusion of the index procedure

  7. Major target extremity amputation [ Time Frame: 1 month,6 months,12 months, 24 months, 36 months ]
  8. Minor target extremity amputation [ Time Frame: 1 month,6 months,12 months, 24 months, 36 months ]
  9. Scaffold Thrombosis [ Time Frame: 1 month,6 months,12 months, 24 months, 36 months ]
  10. Target Lesion binary restenosis by duplex ultrasound Peak Systolic Velocity ratio (PSVR>2.4) [ Time Frame: 1 month, 6 months,12 months, 24 months, 36 months ]
  11. Clinically driven target lesion restenosis defined as any intervention due to worsening symptoms, a fall in ABI or TL restenosis as determined by duplex ultrasound [ Time Frame: 1 month,6 months,12 months, 24 months, 36 months ]
  12. Target extremity revascularisation [ Time Frame: 1 month,6 months,12 months, 24 months, 36 months ]
  13. Primary patency of the target lesion [ Time Frame: 1 month,6 months,12 months, 24 months, 36 months ]
  14. Primary assisted patency of the target lesion [ Time Frame: 1 month,6 months,12 months, 24 months, 36 months ]
  15. Secondary patency of the target lesion [ Time Frame: 1 month,6 months,12 months, 24 months, 36 months ]
  16. Rutherford Becker clinical category [ Time Frame: 1 month,6 months,12 months, 24 months, 36 months ]
  17. Ankle Brachial Index in the target extremity [ Time Frame: 1 month,6 months,12 months, 24 months, 36 months ]
  18. Walking Capacity as demonstrated by the Walking Impairment Questionnaire [ Time Frame: 1 month,6 months,12 months, 24 months, 36 months ]
  19. Quality of Life measures using VASCUQoL- disease specific [ Time Frame: 1 month,6 months,12 months, 24 months, 36 months ]
  20. Duplex ultrasound derived Peak Velocity (PSV) at the target lesion [ Time Frame: 1 month,6 months,12 months, 24 months, 36 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Clinical inclusion criteria:

  1. Subject is ≥18 years of age.
  2. 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.
  3. Subject's life expectancy is at least 1 year.
  4. Subject is diagnosed as having symptomatic claudication (Rutherford-Becker Clinical Category 2-4).
  5. For females of childbearing potential, a negative pregnancy test within 14 days before index procedure is required
  6. Subject is able to take a P2Y12 receptor antagonist (e.g. clopidogrel, ticagrelor, prasugrel or ticagrelor) and acetylsalicylic acid (aspirin).

Angiographic inclusion criteria:

  1. A single, de novo native disease segment of the SFA
  2. Proximal margin of target lesion is ≥1 cm distal to the common femoral artery bifurcation; distal margin of target lesion is within the SFA.
  3. 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.
  4. Target lesion diameter reduction ≥50%
  5. Target lesion length ≤53 mm
  6. Patent inflow artery free from significant lesion (≥50% diameter reduction;
  7. 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.

Exclusion Criteria:

Clinical exclusion criteria:

  1. Previous bypass surgery or stenting at the TL;
  2. 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;
  3. Failure to successfully cross the target lesion with a guide wire;
  4. 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.
  5. Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm;
  6. Subject is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus);
  7. Acute limb ischemia;
  8. History of a bleeding diathesis;
  9. History of a hypercoagulability syndrome;
  10. Platelet count <100,000 cells/mm3 or >700,000 cells/mm3; a WBC <3,000 cells/mm3; or hemoglobin <10.0 g/dL;
  11. Acute or chronic renal dysfunction (creatinine >2.5 mg/dl or >176 μmol/L), or on chronic hemodialysis;
  12. 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;
  13. 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;
  14. Subject requires planned procedure within 30 days that would necessitate the discontinuation of clopidogrel, prasugrel, or ticagrelor;
  15. Subject is on chronic Coumadin therapy
  16. Subject has had or is planned to have treatment with DES or drug coated balloon (DCB) within 90 days pre- or post-index procedure;
  17. Subject is non-ambulatory;
  18. Subject has undergone percutaneous intervention of the coronary, carotid, or arterial bed exclusive of the <30 days prior to the planned index procedure.
  19. Subject has received, or is on the waiting list for, an organ transplant;
  20. Subject had a myocardial infarction (MI) within the previous 30 days prior to the planned index procedure;
  21. Subject has had a stroke within the previous 30 days of the planned index procedure and/or has deficits from a prior stroke that limit the subject's ability to walk;
  22. Subject has unstable angina defined as rest angina with ECG changes;
  23. Subject has a groin infection, or an acute systemic infection that has not been treated successfully or is currently under treatment;
  24. Subject has acute thrombophlebitis (superficial or deep) in either extremity;
  25. Subject has other medical conditions (e.g., cancer, congestive heart failure or substance abuse) that may cause the subject to be non-compliant with protocol requirements or confound data interpretation;
  26. Subject is currently participating or wanting to participate in a clinical trial following 6 months after the index procedure in an investigational drug, biologic, or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials);
  27. Subject is unable to understand or unwilling to cooperate with study procedures;
  28. Subject has prior minor or major amputation of either lower extremity;
  29. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give informed consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy;
  30. Pre-operative plan for additional treatment of the target lesion at the time of the study procedure with alternative therapy such as drug-eluting stent (DES) and scaffold, laser, atherectomy, cryoplasty, cutting balloon, drug-eluting balloon, or brachytherapy (vessel preparation with uncoated balloon angioplasty is allowed); 31Plan for cardiovascular surgical or interventional procedure ≤30 days after the study procedure including planned treatment of the contralateral lower extremity.

Angiographic exclusion criteria:

  1. Target extremity has an angiographically significant (>50% diameter reduction) lesion located in the target vessel distal to the target lesion;
  2. Thrombus in the target vessel;
  3. Stenosis (>50%) or occlusion of an ipsilateral inflow artery;
  4. Angiographic evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion, or from crossing or pre-dilating the target lesion;
  5. Target lesion has calcification with either of the following characteristics:

    • Circumferential orientation, or
    • Thickness >2 mm (radially) within the wall of the target lesion.
  6. Failure to achieve less than 30% residual stenosis after balloon predilation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02869087


Locations
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Austria
LKH University Hospital Graz
Graz, Steiermark, Austria, A8036
Hanusch Hospital
Vienna, Austria, 1140
Belgium
AZ Sint Blasius, Dendermonde
Dendermonde, Brussels, Belgium
Heilig Hart Hospital
Tienen, Belgium
Germany
Bonifatius Hospital
Lingen, Niedersachsen, Germany, 49808
Klinikum Arnsberg
Arnsberg, NRW, Germany, 59759
Heart Center Bad Krozingen
Freiburg, Germany
Universitätsklinikum Leipzig AöR,
Leipzig, Germany
St Franziskus Hospital
Muenster, Germany
New Zealand
Auckland City Hospital
Auckland, New Zealand
Wellington Hospital
Wellington, New Zealand
Sponsors and Collaborators
Elixir Medical Corporation
Syntactx
Massachusetts General Hospital
Genae
Investigators
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Principal Investigator: Marc Bosiers, Doctor AZ Sint-Blasius Dendermonde
Principal Investigator: Dierk Scheinert, Doctor Universitätsklinikum Leipzig
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Responsible Party: Elixir Medical Corporation
ClinicalTrials.gov Identifier: NCT02869087    
Other Study ID Numbers: ELX CL 1501
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases