Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Comparison of Biolimus Eluted From an Erodable Stent Coating With Bare-Metal Stents in Acute ST-Elevation Myocardial Infarction and In Vivo 3-Vessel Assessment of Time-Related Changes of Culprit and Non-Culprit Lesions by IVUS/OCT in AMI
Brief Summary: Stent study:

Treatment of patients with acute myocardial infarction with drug eluting stents (DES) is effective but there remain concerns regarding the long-term safety and adverse effects on the adjacent arterial wall. The biolimus-eluting Biomatrix stent addresses the issues by incorporating modifications as a biodegradable polymer and a drug application solely to the abluminal stent surface. While clinical data about the biolimus-eluting stent show a favorable safety and efficacy profile, they require confirmation in a dedicated randomised trial in the subset of patients with STEMI. Therefore, the study is designed to compare the safety and efficacy of biolimus-eluting Biomatrix stent as compared to a bare metal stent of otherwise identical design in a prospective, multicenter, randomized, controlled superiority trial in patients with acute ST-elevation myocardial infarction.

Stent and Plaque Imaging Substudy:

In a substudy of the above mentioned stent trial, the investigators will perform a prospective, multicenter, longitudinal cohort study of 100 consecutive STEMI patients undergoing urgent coronary angiography and will employ high-resolution Optical Coherence Tomography (OCT) imaging technology and intra-vascular ultrasound and virtual histology (IVUS-VH) of the culprit STEMI lesions pre- and postprocedural as well as at a 13 months follow up. Assessment of vascular wall responses, including volumetric measurements of vessel, stent, lumen, peri-stent plaque, and intimal hyperplasia, indices of remodeling, stent expansion, and stent-vessel wall apposition in response to biolimus-eluting and bare-metal stent implantation will be performed. Moreover, IVUS, IVUS-VH and OCT will be performed in all three epicardial vessels in order to quantify and map the number, frequency and distribution of ruptured plaques at baseline and follow-up and quantify the morphological changes of ruptured and vulnerable plaques at baseline and follow-up and quantify the morphological changes over time in response to standard medical treatment. Therefore, new insight regarding the frequency, distribution, composition and evolution of coronary artery plaques and their prognostic impact on patients clinical outcome can be expected from the present study. Since patients suffer from a recurrent ischemic event rate of 5-10% during the first year, these findings may have important therapeutic implications for the medical treatment of affected patients to further reduce the risk of recurrence and improve prognosis.


Options:
A: Arm Label: Pharmacology Arm; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bivalirudin, Drug: Unfractionated heparin | Arm Label: Stent Arm; Type: ACTIVE_COMPARATOR; Interventions: Device: Bare metal stent, Device: Paclitaxel-eluting stent | Intervention Type: DRUG; Name: Bivalirudin; Assigned to Arm(s): Pharmacology Arm | Intervention Type: DRUG; Name: Unfractionated heparin; Assigned to Arm(s): Pharmacology Arm | Intervention Type: DEVICE; Name: Bare metal stent; Assigned to Arm(s): Stent Arm | Intervention Type: DEVICE; Name: Paclitaxel-eluting stent; Assigned to Arm(s): Stent Arm
B: Intervention Type: DRUG; Name: Angiomax (bivalirudin) anticoagulant; Assigned to Arm(s): N/A
C: Arm Label: Everolimus-eluting bioresorbable vascular scaffold stents; Type: ACTIVE_COMPARATOR; Interventions: Device: Implantation of everolimus-eluting bioresorbable vascular scaffold stent | Arm Label: Everolimus-eluting stent; Type: ACTIVE_COMPARATOR; Interventions: Device: Implantation of everolimus-eluting stents | Arm Label: Biolimus-eluting stent; Type: ACTIVE_COMPARATOR; Interventions: Device: Implantation of biolimus-eluting stents | Intervention Type: DEVICE; Name: Implantation of everolimus-eluting bioresorbable vascular scaffold stent; Assigned to Arm(s): Everolimus-eluting bioresorbable vascular scaffold stents | Intervention Type: DEVICE; Name: Implantation of everolimus-eluting stents; Assigned to Arm(s): Everolimus-eluting stent | Intervention Type: DEVICE; Name: Implantation of biolimus-eluting stents; Assigned to Arm(s): Biolimus-eluting stent
D: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Device: Biolimus eluted from an erodable stent coating (Biomatrix) | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Device: bare-metal stent (Gazelle) | Intervention Type: DEVICE; Name: Biolimus eluted from an erodable stent coating (Biomatrix); Assigned to Arm(s): 1 | Intervention Type: DEVICE; Name: bare-metal stent (Gazelle); Assigned to Arm(s): 2

Answer: D