A Comparison Between Paclitaxel-eluting Balloon in Combin... | NCT01637896

Studies
A Comparison Between Paclitaxel-eluting Balloon in Combination With BMS Implantation vs Conventional Balloon and DES Implantation

NCT01637896

Sponsor

Leonardo Bolognese, MD

Status

Terminated

Last Update Posted

Jul 12, 2012Estimated

Enrollment

125Actual

Phase

Phase 4

Conditions

Myocardial Ischemia

Interventions

DEB+BMS
POBA+DES

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

the study was halted after an interim analysis perfomed for a perceived excess of target vessel revascularization in the DEB+BMS arm

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Dec 2011Actual

Completion Date

Jul 2012Actual

First Submitted Date

Jul 7, 2012

First Submission Date that Met QC Criteria

Jul 7, 2012

First Posted Date

Jul 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2012

Last Update Posted Date

Jul 12, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Leonardo Bolognese, MD, Director, Ospedale San DonatoSponsor-Investigator

Lead Sponsor

Leonardo Bolognese, MDOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

125Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
DEB+BMS	Device	drug-eluting balloon predilation and bare metal stent implantation	DEB+BMS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
angiographic binary re-restenosis	incidence of angiographic binary re-restenosis	9 months

Secondary Outcomes

Measure	Description	Time Frame
Late luminal loss	incidence of late luminal loss assessed by angiography	9 months
major adverse cardiac events	incidence of major adverse cardiac events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leonardo Bolognese, MD	San Donato Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiovascular Department, Ospedale S.Donato		Arezzo	AR	52100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D017202	Myocardial Ischemia

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided