Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Hospital District of Satakunta | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare vascular healing of the stented segment after deployment of new PRO-Kinetic drug eluting stent and Endeavor Resolute zotarolimus-eluting stent in patients with acute coronary syndromes requiring percutaneous coronary intervention.
Objective: The aim of the trial is to compare vascular healing and vasodilation at 3 months after deployment of PRO-Kinetic drug-eluting stent and Endeavor Resolute zotarolimus-eluting stent in patients with acute coronary syndrome.
Design: A prospective, randomized and controlled study comparing coronary flow reserve and coverage of the PRO-Kinetic DES and Endeavor Resolute DES implanted in acute coronary syndrome. OCT and CFR measurement at 3 months. Clinical follow up is scheduled at 3, 6 and 12 months.
Primary endpoint: Uncovered stent struts and CFR at 3 months after stent implantation.
Secondary clinical endpoints: MACE and stent thrombosis.
Enrollment: 40 patients (20 receiving PRO-Kinetic DES and 20 receiving Endeavor Resolute DES).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO-Kinetic DES | Patients receiving PRO-Kinetic drug-eluting stent |
| |
| Endeavor Resolute DES | Patient receiving Endeavor Resolute zotarolimus-eluting stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCT | Device | Optical coherence tomography |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Uncovered stent struts | Percentage of uncovered stent struts per stent by OCT | 3 months |
| Coronary flow reserve | Coronary flow reserve by transthoracic echocardiography. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| MACE and target vessel stent thrombosis | Death, MI (Q wave or non-Q wave), emergent CABG, or justified TLR by repeat PCI or CABG, and target vessel stent thrombosis. | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients with acute coronary syndrome treated with PRO-Kinetic DES or Endeavor Resolute DES during index PCI.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tuomas Kiviniemi, MD, PhD | Turku University Hospital | Principal Investigator |
| Pasi Karjalainen, MD, PhD | Satakunta Central Hospital | Principal Investigator |
| Antti Ylitalo, MD, PhD | Satakunta Central Hospital | Principal Investigator |
| Juhani Airaksinen, MD, PhD, FESC | Turku University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Satakunta Central Hospital, Pori | Pori | 28500 | Finland | |||
| Turku University Hospital |
Not provided
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Serum, plasma
| Transthoracic echocardiography CFR measurement |
| Device |
CFR will be assessed using transthoracic echocardiography with adenosine infusion. |
|
| Turku |
| 20520 |
| Finland |