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Drug Impregnated Bioabsorbable Stent in Asian Population Extremity Arterial Revascularization (DISAPEAR Study) (DISAPEAR)

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ClinicalTrials.gov Identifier: NCT02043795
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Changi General Hospital

Brief Summary:
The aim of this study is to study the safety and clinical efficacy of a novel Bioabsorbable Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS, Abbott Vascular) in subjects with critical limb ischemia (CLI) following percutaneous transluminal angioplasty (PTA) of the tibial arteries.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Device: BVS, Abbott Vascular Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Drug Impregnated Bioabsorbable Stent in Asian Population Extremity Arterial Revascularization (DISAPEAR Study)
Actual Study Start Date : July 1, 2013
Actual Primary Completion Date : March 19, 2018
Actual Study Completion Date : February 2019

Arm Intervention/treatment
Treated with BVS
Symptomatic patients would be screened with a duplex ultrasound as per clinical practice prior to intervention. After informed consent for a standard angiography/intervention, the patient will undergo a planned intervention under general or local anaesthesia in an angiographic facility.
Device: BVS, Abbott Vascular
The aim of this study is to study the safety and clinical efficacy of a novel Bioabsorbable Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS, Abbott Vascular).
Other Name: Bioresorbable Vascular Scaffold System




Primary Outcome Measures :
  1. Change in Re-stenosis rates between 6 months and 12 months [ Time Frame: 6 months and 12 months ]
    defined at stenosis >=50% of the treated segment on duplex ultrasound, CT angiography or MR angiography


Secondary Outcome Measures :
  1. Change in Mean Transcutaneous oxygen measurement (TCOMs) between 6 months and 12 months [ Time Frame: 6 and 12 months ]
    Change in Mean Transcutaneous oxygen measurement (TCOMs)

  2. Change in Amputation free survival between 6 months and 12 months [ Time Frame: 6 months and 12 months ]
  3. Change in Freedom from Target lesion revascularization between 6 months and 12 months [ Time Frame: 6 and 12 months ]
  4. Change from baseline in Rutherford class at 6 months and 12 months [ Time Frame: Baseline, 6 and 12 months ]
  5. Number of Participants with major adverse limb events (MALE) [ Time Frame: within 1 year ]
    Freedom from major adverse limb events (MALE) within 1 year

  6. Number of Participants with Peri-procedural death (POD) [ Time Frame: within 30-day ]
    Freedom from peri-procedural (30-day) death (POD)


Other Outcome Measures:
  1. Sensitivity and specificity of each imaging modality [ Time Frame: 1 year ]
    Imaging features of the Bioabsorbable Everolimus Eluting Bioresorbable Vascular Scaffold System would be evaluated on the various imaging modalities, like possible streak artefacts on CT scan and susceptibility on MR. Sensitivity and specificity of each imaging modality will be compared with one another as well as those in the literature.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Criteria for Recruitment

At the investigator site, the investigators will recruit patients in accordance to the study protocol, local regulatory requirements, and the ICH-GCP guidelines. When a patient is identified, he/she will be informed about the study. The study will be fully explained to the patient including study objectives, methods, anticipated benefits/risks and discomforts he or she may experience. Summary of this information will be provided in writing using the Informed Consent Form. Patients will be given the opportunity to clarify any issues/questions with the investigator and given adequate time to consider participating in the study or not. Signed and dated informed consent of the patients will be obtained before the commencement of any study related procedures.

Inclusion Criteria:

  • Stenotic (> 50%) or occlusive atherosclerotic disease of the infrapopliteal arteries
  • A maximum of 2 target lesions in one or more infrapopliteal vessels
  • Minimum of 1mm overlap of stents
  • Reference vessel diameter should be 2-4.0 mm
  • Symptomatic critical limb ischemia (Rutherford 4, 5, 6)
  • The patient must be > 21 years of age
  • Life-expectancy of more than 12 months
  • The patient has no child bearing potential or negative serum pregnancy test within 7 days of the index procedure
  • The patient must be willing and able to return to the appropriate follow-up times for the duration of the study
  • The patient must provide written patient informed consent

Exclusion Criteria:

  • Patient refusing treatment
  • The reference segment diameter is not suitable for available stent design
  • Unsuccessfully treated (>50% residual stenosis) proximal inflow limiting arterial stenosis
  • Untreatable lesion located at the distal outflow arteries
  • Lesion location requiring kissing stent procedure
  • The patient has a known allergy to heparin, Aspirin or other anticoagulant/anti-platelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
  • The patient takes Phenprocoumon (Marcumar).
  • The patient is currently breast-feeding, pregnant or intends to become pregnant.
  • Subject is receiving immunosuppression therapy, or has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.) The patient should also not receive inhibitors of CYP3A (such as Itraconazole, and Erythromycin), or inducers of CYP3A (such as Rifampin) within 90 days following the procedure.
  • Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure to the target vessel

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): NCT02043795


Locations
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Singapore
Changi General Hospital
Singapore, Singapore, 529889
Sponsors and Collaborators
Changi General Hospital
Investigators
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Principal Investigator: Steven Kum, MD Changi General Hospital
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Responsible Party: Changi General Hospital
ClinicalTrials.gov Identifier: NCT02043795    
Other Study ID Numbers: 2013/539/C
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Keywords provided by Changi General Hospital:
Bioresorbable Vascular Scaffold System
Percutaneous Transluminal Angioplasty
Stent
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes