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Drug-coated Balloon Versus Drug-eluting Stent in Acute Myocardial Infarction

NCT02219802 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2014-08-19

No results posted yet for this study

Summary

Rationale: Compared with balloon angioplasty, implantation of bare metal stents (BMS) and drug eluting stents (DES) have shown to reduce repeat target lesion revascularization in primary percutaneous coronary intervention (PPCI). However, this did not result in a reduction of mortality or recurrent myocardial infarction. Furthermore, there are concerns of the occurrence of stent thrombosis. The PAPPA-pilot study, evaluating safety and feasibility of using a drug-coated balloon (DCB) only strategy in PPCI, showed good short- and long-term clinical results, with sustained safety and efficacy at 12 months follow-up. To date little is known about the long-term effects of this treatment modality in STEMI. Besides, angiographic follow-up is of great clinical importance by giving insight on the treated infarct lesion and to assess the functional angioplasty result.

Objective: This randomized controlled, non-inferiority trial is mainly designed to prospectively assess the safety and efficacy of a CE-marked paclitaxel-eluting balloon only strategy vs. third generation DES in the setting of a ST-elevation myocardial infarction (STEMI).

Conditions

Interventions

PROCEDURE

Treatment according arm

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    collaborator INDUSTRY

  • Volcano Corporation

    collaborator INDUSTRY

  • Onze Lieve Vrouwe Gasthuis

    lead OTHER

Principal Investigators

  • R. J. van der Schaaf, MD, PhD · OLVG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02219802 on ClinicalTrials.gov