Deferred Stent Trial in STEMI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

During primary PCI, stent deployment and post-dilatation are associated with no-reflow. The mechanisms for no reflow include distal embolization of thrombus, enhanced thrombus formation and vascular spasm. No reflow is associated with risk factors such as prolonged duration of ischaemia, heavy thrombus burden, persistent ST elevation and long stent length. ACTIVE HYPOTHESIS: once normal antegrade flow has been re-established with initial aspiration thrombectomy and/or balloon angioplasty at the beginning of primary PCI, compared with usual care with direct stenting, a strategy of deferred stenting for 4 -16 hours to permit the beneficial effects of normalized coronary blood flow and anti-thrombotic therapies will reduce the incidence of no reflow in at-risk STEMI patients. DESIGN: In consecutive STEMI patients with risk factors for no reflow and who have given informed consent, when normal flow has been established (TIMI 3) by initial aspiration thrombectomy and/or balloon angioplasty, participants will be randomized to deferred stenting or usual care with direct stenting. All patients will receive dual anti-platelet therapy. Patients who are randomized to deferred stenting will receive intravenous glycoprotein IIbIIIa inhibitor and anti-coagulation with low molecular weight heparin. Patients who are screened and not eligible to be randomized will be prospectively entered into a registry. Study assessments for feasibility, safety and efficacy will be prospectively performed. An independent clinical event committee will review all serious adverse events. Study endpoints will be subject to core laboratory analyses. The study is intended to inform the design of a larger multicentre clinical trial.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

No Reflow Phenomenon Incidence and Predictors

NCT04017169

No Reflow Phenomenon STEMI

COMPLETED

PrOgnostic imPlicaTIons of 2-diMensIonal Patterns for Residual Disease After Stenting CharacteriZEd by Quantitative Flow Ratio Pullback Curve Analysis

NCT05125107

Coronary Artery Disease

UNKNOWN

Flow Patterns and Stent Thrombosis

NCT06700018

Stent Thrombosis

RECRUITING

Molecular and Cellular Mechanisms of the In-stent-thrombosis

NCT00652015

Patients With SAT or LT After Stent Implantation (PCI)

WITHDRAWN

Fractional Flow Reserve (FFR) Stability in Non-Culprit Vessels at ST Elevation Myocardial Infarction(STEMI)

NCT01065103

Myocardial Infarction

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ST-Elevation Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Deferred stenting

During primary PCI in STEMI, when TIMI 3 flow has been re-established with guide-wire, aspiration thrombectomy and/or balloon angioplasty, stenting is then deferred for a period of 4-16 hours following reperfusion. During this time, patients remain in the Coronary Care Unit and will receive intravenous tirofiban and subcutaneous low molecular weight heparin (enoxaparin 1 mg/kg)

Group Type ACTIVE_COMPARATOR

Deferred stenting

Intervention Type PROCEDURE

Conventional treatment

Conventional treatment in STEMI, with immediate stenting

Group Type SHAM_COMPARATOR

Conventional treatment

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Deferred stenting

Intervention Type PROCEDURE

Conventional treatment

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Rescue PCI
* Prolonged ischaemic time (\> 12hours)
* Previous MI
* Age \> 65
* Occluded artery (TIMI 0/1) at initial angiography
* Thrombus burden (TIMI grade 2+)
* Long plaque/ stent length (\> 24 mm)
* Severe coronary artery disease (e.g calcified artery)
* Small reference vessel diameter (\< 2.5 mm)
* Persistent ST-elevation (\> 50%) following reperfusion
* Index of microvascular resistance (IMR) \> 40