NCT01637896

Brief Summary

The purpose of this study is to evaluate the efficacy of predilation with paclitaxel-eluting balloon and bare metal stent implantation VS conventional balloon and drug-eluting stent implantation in terms of restenosis

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
Last Updated

July 12, 2012

Status Verified

July 1, 2012

Enrollment Period

1.5 years

First QC Date

July 7, 2012

Last Update Submit

July 11, 2012

Conditions

Myocardial Ischemia

Outcome Measures

Primary Outcomes (1)

  • angiographic binary re-restenosis

    incidence of angiographic binary re-restenosis

    9 months

Secondary Outcomes (2)

  • Late luminal loss

    9 months

  • major adverse cardiac events

    12 months

Study Arms (2)

DEB+BMS

EXPERIMENTAL

drug-eluting balloon predilation and bare metal stent implantation

Device: DEB+BMS

POBA+DES

ACTIVE COMPARATOR

conventional balloon predilation and drug-eluting stent implantation

Device: POBA+DES

Interventions

DEB+BMSDEVICE

drug-eluting balloon predilation and bare metal stent implantation

DEB+BMS
POBA+DESDEVICE

conventional balloon predilation and drug-eluting stent implantation

POBA+DES

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age\> 18 years
  • angina or stress test positive for ischemia
  • de novo coronary stenosis\>50%

You may not qualify if:

  • recent myocardial infarction (\<72h)
  • severe chronic kidney disease
  • allergy to Paclitaxel
  • contraindication for combined antiplatelet treatment
  • life expectancy \<1 year
  • hypersensitivity or contraindication to one of the study drugs
  • lack of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Department, Ospedale S.Donato

Arezzo, AR, 52100, Italy

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Leonardo Bolognese, MD

    San Donato Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 7, 2012

First Posted

July 11, 2012

Study Start

June 1, 2010

Primary Completion

December 1, 2011

Study Completion

July 1, 2012

Last Updated

July 12, 2012

Record last verified: 2012-07

Locations

IT(1)