Prospective Clinical Observational Registry Including Consecutive Patients With In-stent Restenosis or Stent Thrombosis

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2007
Prospective clinical observational registry study including consecutive patients with clinical signs or symptoms due to in-stent restenosis (ISR) or definite (ARC criteria) stent thrombosis (ST). Study hypothesis: Initial Stent implantation quality (due to technique/problems) are possible major determinants of ST and ISR in real life practice. Both early, late, and very late ST, and ISR are important factors for long term outcome after initial stent implantation. Primary objective: * To elucidate the possible cause(s) of thrombosis or restenosis after stent implantation in real life practice by clinical, angiographic and IVUS evaluation. Secondary objective: * To describe the clinical manifestation \[stable angina pectoris (AP), unstable AP, non-ST-elevation myocardial infarction (NSTEMI), or ST-elevation MI\] of the index event (inclusion). * To describe the characteristics of patient, lesion and procedure of the initial percutaneous coronary intervention (PCI). * To describe the antithrombotic pharmacological therapy preceding the index event. * To describe clinical outcome (death, MI, revascularization, CCS angina class) following treatment of the index event during 12 month follow-up. * To describe safety of the IVUS procedure (product or procedural related complications/ malfunctions).
Epistemonikos ID: a3aed7cfc165597dfa7306cbb5861b51d030de0f
First added on: May 04, 2024