Coronary Artery Disease Clinical Trial
Official title:
Evaluation of Effectiveness and Safety of Resolute Integrity DES in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study (IRIS-Integrity)
| NCT number | NCT01392846 |
| Other study ID # | CVRF2011-07 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 2011 |
| Est. completion date | March 2, 2020 |
| Verified date | September 2021 |
| Source | CardioVascular Research Foundation, Korea |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This is a prospective, observational, cohort study to evaluate the relative efficacy and safety of Resolute Integrity stent compared to other (drug eluting stents) DES.
| Status | Completed |
| Enrollment | 3000 |
| Est. completion date | March 2, 2020 |
| Est. primary completion date | January 20, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Patients with significant coronary artery disease and receiving Resolute Integrity stent. - The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site. Exclusion Criteria: - Patients with a mixture of other DESs - Terminal illness with life expectancy <1 year - Patients presented with cardiogenic shock |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Hallym University Sacred Heart Hospital | Anyang | |
| Korea, Republic of | Soon Chun Hyang University Hospital Bucheon | Bucheon | |
| Korea, Republic of | The Catholic University of Korea, Bucheon ST.Mary's Hospital | Bucheon | |
| Korea, Republic of | Soon Chun Hyang University Hospital Cheonan | Cheonan | |
| Korea, Republic of | Daegu Catholic University Medical Center | Daegu | |
| Korea, Republic of | Kyungpook National University Hospital | Daegu | |
| Korea, Republic of | Yeungnam University Medical Center | Daegu | |
| Korea, Republic of | The Catholic University of Korea, Daejeon ST.Mary's Hospital | Daejeon | |
| Korea, Republic of | Gang Neung Asan Hospital | Gangneung | |
| Korea, Republic of | Chonnam National University Hospital | Gwangju | |
| Korea, Republic of | Inje University Ilsan Paik Hospital | Ilsan | Gyeong-gi |
| Korea, Republic of | National Health Insurance Corporation Ilsan Hospital | Ilsan | |
| Korea, Republic of | Gachon University Gil Hospital | Incheon | |
| Korea, Republic of | Presbyterian Medical Center | Jeonju | |
| Korea, Republic of | Kwangju Christian Hospital | Kwangju | |
| Korea, Republic of | Pusan National University Yangsan Hospital | Pusan | |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Gangnam Severance Hospital | Seoul | |
| Korea, Republic of | Kangdong Sacred Heart Hospital | Seoul | |
| Korea, Republic of | Korea University Guro Hospital | Seoul | |
| Korea, Republic of | St.carollo Hospital | Suncheon | |
| Korea, Republic of | The Catholic University of Korea Uijeongbu St. Mary's Hospital | Uijeongbu | |
| Korea, Republic of | Ulsan University Hospital | Ulsan |
| Lead Sponsor | Collaborator |
|---|---|
| Seung-Jung Park | CardioVascular Research Foundation, Korea, Medtronic |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | composite of death, nonfatal myocardial infarction (MI), or target- Vessel Revascularization (TVR) | 12 months post procedure | ||
| Secondary | Death (all cause and cardiac) | one month | ||
| Secondary | Death (all cause and cardiac) | 6 months | ||
| Secondary | Death (all cause and cardiac) | 12 months and yearly up to 5 years | ||
| Secondary | Myocardial Infarction | one month | ||
| Secondary | Myocardial Infarction | 6 months | ||
| Secondary | Myocardial Infarction | 12 months and yearly upto 5 years | ||
| Secondary | Composite of death or MI | one month | ||
| Secondary | Composite of death or MI | 6 months | ||
| Secondary | Composite of death or MI | 12 months and yearly upto 5 years | ||
| Secondary | Composite of cardiac death or MI | one month | ||
| Secondary | Composite of cardiac death or MI | 6 months | ||
| Secondary | Composite of cardiac death or MI | 12 months and yearly up to 5 years | ||
| Secondary | Target Vessel Revascularization | one month | ||
| Secondary | Target Vessel Revascularization | 6 months | ||
| Secondary | Target Vessel Revascularization | 12 months and yearly up to 5 years | ||
| Secondary | Target-lesion revascularization | one month | ||
| Secondary | Target-lesion revascularization | 6 months | ||
| Secondary | Target-lesion revascularization | 12 months and yearly up to 5 years | ||
| Secondary | Stent thrombosis | one month | ||
| Secondary | Stent thrombosis | 6 months | ||
| Secondary | Stent thrombosis | 12 months and yearly up to 5 years | ||
| Secondary | Stroke | 12 months and yearly up to 5 years | ||
| Secondary | Procedural success | It is defined as achievement of a final diameter stenosis of <30% by visual estimation, without the occurrence of death, Q-wave MI, or urgent revascularization during the index hospitalization. | at day 1 |
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