Clinical Trials Logo

Clinical Trial Summary

Patients presenting with acute ST elevation myocardial infarct urgently need revascularization. Standard of care is establishing bloodflow through the coronary vessels using thrombus aspiration catheter, and securing the result by using a metallic drug eluting stent. New kinds of non-metallic bioresorbable stents are now available. They have however challenges in structural strength.

The investigators want to compare the new bioresorbable scaffold with traditional metallic stents in this setting in a prospective, randomized, non-blinded, multicenter study in 120 patients. The investigators will use an imaging technique, optical coherence tomography, to evaluate the results after 12 months.

The investigators also want to see if modern multislice computed tomography can give useful information in the follow-up of stented coronary arteries after 12 and 24 months.


Clinical Trial Description

Patients presenting with ST elevation myocardial infarction for primary PCI (percutaneous coronary intervention) will be screened. After thrombus aspiration, patient will be asked for oral consent if TIMI flow 2-3. Patient will then be randomized between drug eluting stent (Xience pro, Abbott Vascular Solutions) and bioresorbable scaffold (Absorb, Abbott Vascular Solutions). Optical coherence tomography (OCT) will be performed before stenting and after final result. Stent will be deployed without further predilatation if possible. Follow up at 12 months (clinical, angio with OCT and multislice CT coronary angiogram (MSCT-CA)) and 24 months (MSCT-CA). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02067091
Study type Interventional
Source Haukeland University Hospital
Contact
Status Active, not recruiting
Phase Phase 3
Start date August 2014
Completion date August 2020

See also
  Status Clinical Trial Phase
Active, not recruiting NCT06435728 - Predictive Value of Combining AccuIMR and AccuFFR in Patients With STEMI
Completed NCT02914795 - Platelet Function in Resuscitated Patients
Recruiting NCT00697021 - Thromboelastography As An Assessment Tool for Possible Clopidogrel and Aspirin Resistance Phase 3
Completed NCT05949515 - Retrospective Evaluation of SuperSaturated Oxygen (SSO2) Therapy Clinical Utility
Completed NCT02828683 - Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in STEMI Patients - MASTER Study N/A
Completed NCT01986803 - ABSORB STEMI: the TROFI II Study N/A
Active, not recruiting NCT01878344 - Effects of N-acetyl Cysteine During Primary Percutaneous Coronary Intervention Phase 3
Withdrawn NCT02048085 - Comparing Ticagrelor and Clopidogrel Pharmacodynamics After Thrombolysis Phase 4
Completed NCT04463251 - Study to Evaluate the Effect on Parameters of Systemic Inflammation and Disease Outcomes and Safety of RPH-104 in Subjects With Acute ST-elevation Myocardial Infarction Phase 2
Active, not recruiting NCT02943954 - FLOW Evaluation to Guide Revascularization in Multi-vessel ST-elevation Myocardial Infarction N/A
Completed NCT02298088 - Ticagrelor in Patients With ST Elevation Myocardial Infarction Treated With Pharmacological Thrombolysis Phase 3
Completed NCT01787110 - An Efficacy and Outcome Study of Supplemental Oxygen Treatment in Patients With Suspected Myocardial Infarction Phase 3
Recruiting NCT03137212 - Safety and Efficacy of Percutaneous Coronary Intervention Combined With Thrombolysis at Different Time N/A
Not yet recruiting NCT05802667 - A Cohort Study of Correlation Between Mast Cells and Prognosis in Patients With Acute Myocardial Infarction
Completed NCT04730778 - Predictive Value of CHA2DS2VASC Score for Contrast-induced Nephropathy After Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients