Closed Versus Open Cells Stent for Acute Myocardial Infarction

NCT01152138 | Completed

• 1 other identifier: COCHISE
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to determine whether a closed cell stent design may reduce distal embolization and no reflow during primary percutaneous coronary intervention (PPCI) for acute ST-elevation acute myocardial infarction (STEMI) compared to an open cell stent design. The study population will include all consecutive patients admitted for acute STEMI and treated with PPCI within 12 hours from symptom onset.

Conditions

Acute Myocardial Infarction; Primary Percutaneous Coronary Intervention

Keywords

Acute myocardial infarction; Closed cell stent; Open cell stent; primary percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• Post procedural angiographic evaluation

  The corrected Thrombolysis In Myocardial Infarction (TIMI) frame count at the end of the procedure defined as the number of frames required to opacify angiographic landmarks and normalized for vessel length and a composite end-point including angiographic events such as distal embolization, slow-flow (decrease in flow from TIMI 3 to TIMI 2) or no-reflow (decrease from TIMI 2 or 3 to TIMI 0 or 1) and a binary electrocardiographic criterion of microvascular injury as defined by the presence of persistent (\>50% of initial value) ST-segment elevation 30-60 min after procedure

  whithin 1 day

Secondary Outcomes (1)

• Post stent angiographic results and in hospital MACE

  whithin 7 days

Study Arms (2)

Open Cell Stent

ACTIVE COMPARATOR

Open cell stent (Driver™ or Integrity™,Medtronic), routinely employed during percutaneous coronary interventions for ST elevation acute myocardial infarction

Device: Open cells stent

Closed Cell Stent

ACTIVE COMPARATOR

Closed cell stent (Presillion Plus™, Cordis), routinely employed during percutaneous coronary interventions for ST elevation acute myocardial infarction

Device: Closed Cells Stent

Interventions

Open cells stent DEVICE

Cobalt Chromium Stent with open cell design

Also known as: Driver Stent, Medtronic, Integrity Stent, Medtronic

Open Cell Stent

Closed Cells Stent DEVICE

Cobalt Chromium stent with closed cell design

Also known as: Presillion Plus Stent, Cordis

Closed Cell Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with an age \> 18 years with acute ST elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PPCI) within 12 hours from symptom onset and who agree and provide written informed consent. STEMI is defined as chest pain associated with ST-elevation of 1 mm or more in two or more contiguous leads or new left bundle-branch block within 12 hours after the onset of chest pain

You may not qualify if:

• implanted stent with diameter \< 2.5 mm
• cardiogenic shock
• time from pain onset to PPCI \>12 hours
• previous thrombolytic therapy (rescue PPCI)
• inability to provide informed consent.

Sponsors & Collaborators

• Alessandro Sciahbasi: lead

Study Sites (2)

UOC Cardiologia - Policlinico Casilino - ASL RMB

Rome, Italy

Location

UOC Cardiologia - Ospedale Belcolle

Viterbo, Italy

Location

MeSH Terms

Interventions

Stents

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Alessandro Sciahbasi, MD

  Policilnico Casilino - ASL RMB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: June 29, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 17, 2012

Record last verified: 2012-05

Locations

IT (2)