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Trial record 26 of 89 for:    Recruiting, Not yet recruiting, Available Studies | Angioplasty

REal World Advanced Experience of BioResorbable ScaffolD by SMart Angioplasty Research Team (SMART REWARD)

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ClinicalTrials.gov Identifier: NCT02601404
Recruitment Status : Recruiting
First Posted : November 10, 2015
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Hyeon-Cheol Gwon, Samsung Medical Center

Brief Summary:

Current drug-eluting stents (DES) has demonstrated excellent clinical outcomes in patients with coronary artery disease. However, a continued risk of clinical events even several years after the procedure is reported. Stent platform or polymer-associated inflammation may play a role.

Bioresorbable scaffold (BRS) is known to disappear 2 to 3 years after the implantation, which may result in the more favorable very long-term clinical outcomes compared with metallic stents. The initial clinical experiences of BRS in relatively simple lesion subsets were comparable to DESs.

BRS, however, is limited by the disadvantageous mechanical characteristics such as thick strut and the risk of fracture by overdilation. There is concern that BRS is less optimal for complex lesion subsets such as bifurcation lesions, calcified tortuous lesions, or diffuse long lesions. Real world registry is needed to test the feasibility and safety of BRS in these complex lesion subsets.


Condition or disease Intervention/treatment
Acute Coronary Syndromes Device: Bioresorbable scaffold (BRS)

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: REal World Advanced Experience of BioResorbable ScaffolD by SMart Angioplasty Research Team (SMART REWARD)
Actual Study Start Date : November 2015
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Group/Cohort Intervention/treatment
Bioresorbable Scaffold
Patients receiving percutaneous coronary intervention (PCI) for coronary artery disease using Absorb™(Abbott Vascular)
Device: Bioresorbable scaffold (BRS)
The implantation procedure of an Absorb™ is similar to a metallic stent.
Other Name: Absorb™ (Abbott Vascular)




Primary Outcome Measures :
  1. cardiac death [ Time Frame: 2 years ]
    Target vessel failure (TVF) of cardiac death, myocardial infarction (MI) attributed to the target vessel, and target vessel revascularization (TVR)


Secondary Outcome Measures :
  1. Device success [ Time Frame: maximum of 7 days ]
    Successful delivery and deployment of the study scaffold at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable).

  2. Procedural success [ Time Frame: maximum of 7 days ]
    Achievement of final in-scaffold residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat target lesion revascularization (TLR) during the hospital stay (maximum of 7 days).

  3. Target vessel failure (TVF) [ Time Frame: 1, 3, and 5 years ]
    cardiac death, target vessel MI, or TVR

  4. Each component of Target vessel failure (TVF) [ Time Frame: 1, 2, 3 and 5 years ]
    Cardiac death,Vascular death,Non-cardiovascular death,Myocardial Infarction (MI)

  5. Target lesion failure [ Time Frame: 1, 2, 3 and 5 years ]
    Target lesion failure of cardiac death, MI attributed to the target vessel, and Target Lesion Revascularization(TLR). TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself.

  6. Definite or probable stent thrombosis [ Time Frame: 1, 2, 3 and 5 years ]
  7. Periprocedural enzyme elevation [ Time Frame: 1, 2, 3 and 5 years ]


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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A total of 1,000 patients derived from a population of Korean patients receiving PCI for coronary artery disease will be enrolled in the present registry. It is recommended that each enrolling investigator review the most recent instructions for use (IFU) of Absorb™ and assess the contraindications, warnings, and precaution sections for treating potential patients.
Criteria

Inclusion Criteria:

  • Subject must be between 19 and 70 years old.
  • Patients with a significant lesion in a de novo coronary artery: a percent diameter stenosis (DS) 50% with 1) a positive history of recurrent angina pectoris; (2) objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent); or (3) abnormal results of any invasive functional diagnostic test (eg, fractional flow reserve) or a percent DS ≥70% even in the absence of the above-mentioned ischemic signs or symptoms.
  • Patients are scheduled for coronary intervention
  • He/she or his/her legally authorized representative provides written informed consent

Exclusion Criteria:

  • Experience of cardiopulmonary resuscitation
  • Cardiogenic shock
  • Expected survival less than 2 years
  • Pregnancy or breast feeding
  • Opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results

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): NCT02601404


Contacts
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Contact: HyeonCheol Gwon, MD,Ph.D. 2-3410-3418 ext 82 hc.gwon@samsung.com

Locations
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Korea, Republic of
Cardiac and Vascular Center; Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Hyeon-Cheol Gwon, Professor    82234103419    hc.gwon@samsung.com   
Sponsors and Collaborators
Samsung Medical Center

Additional Information:

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Responsible Party: Hyeon-Cheol Gwon, MD,PhD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02601404     History of Changes
Other Study ID Numbers: 2015-07-163
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases