Clinical trial NCT02601404: REal World Advanced Experience of BioResorbable ScaffolD by SMart Angioplasty Research Team (SMART REWARD)
Official title: REal World Advanced Experience of BioResorbable ScaffolD by SMart Angioplasty Research Team (SMART REWARD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndromes
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2015-11-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: cardiac death
timeFrame: 2 years
Secondary outcomes:
measure: Device success
timeFrame: maximum of 7 days
measure: Procedural success
timeFrame: maximum of 7 days
measure: Target vessel failure (TVF)
timeFrame: 1, 3, and 5 years
measure: Each component of Target vessel failure (TVF)
timeFrame: 1, 2, 3 and 5 years
measure: Target lesion failure
timeFrame: 1, 2, 3 and 5 years
measure: Definite or probable stent thrombosis
timeFrame: 1, 2, 3 and 5 years
measure: Periprocedural enzyme elevation
timeFrame: 1, 2, 3 and 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Cardiac and Vascular Center; Samsung Medical Center
Study officials:
References: