The Treatment of Coronary De-novo Lesions With the Elutax... | NCT01899235

Studies
The Treatment of Coronary De-novo Lesions With the Elutax Paclitaxel-eluting Balloon Alone, a Pilot Study

NCT01899235

Sponsor

Aalborg University Hospital

Status

Terminated

Last Update Posted

Mar 18, 2014Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Stable Angina
Coronary Stenosis

Interventions

drug eluting balloon
drug eluting stent

Countries

Denmark

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

Mar 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow recruitment

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Jul 11, 2013

First Submission Date that Met QC Criteria

Jul 12, 2013

First Posted Date

Jul 15, 2013Estimated

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

Mar 15, 2014

Last Update Posted Date

Mar 18, 2014Estimated

Name	Class
Aachen Resonance GmbH	INDUSTRY

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

A randomised open-label pilot study to assess the safety and efficacy of treatment with a drug eluting balloon alone in coronary de novo lesions). Elective patients requiring PCI to coronary de novo lesions in vessels 2.5 mm - 4.0 mm.

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

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stent	Active Comparator	drug eluting stent (Resolute)	Device: drug eluting stent
drug eluting balloon	Experimental	drug eluting balloon (Elutax)	Device: drug eluting balloon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
drug eluting balloon	Device		drug eluting balloon
drug eluting stent

Measure	Description	Time Frame
Major adverse cardiac events		3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient ≥ 18years old
Stable angina symptoms
Elective treatment to coronary lesion
Reference vessel diameters of ≥ 2.5mm and ≤ 4.0 mm on visual inspection

Exclusion Criteria:

Left main stem lesion
Bifurcation lesions
Acute coronary syndrome (UAP, NSTEMI, STEMI)
Cardiogenic shock
Chronic total occlusion
Additional lesions requiring PCI
Platelet count ≤ 50 x 109/mm3
Left ventricular ejection fraction ≤ 30%
Patient life expectancy less than 12 months
Known allergies to aspirin, clopidogrel, prasugrel, heparin, stainless steel, intravenous contrast (severe), or paclitaxel
Participation in another investigational drug or device study
Patient unable to give informed 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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aalborg University Hospital		Aalborg		9000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D060050	Angina, Stable
D023921	Coronary Stenosis

Ancestor Terms

ID	Term
D000787	Angina Pectoris
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D054855	Drug-Eluting Stents

Ancestor Terms

ID	Term
D015607	Stents
D019736	Prostheses and Implants
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided