Use of Different Diagnostic Coronary Catheters Over the R... | NCT02947542

Studies
Use of Different Diagnostic Coronary Catheters Over the Radial Access - the UDDC - Radial Trial

NCT02947542

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

May 16, 2017Actual

Enrollment

300Actual

Phase

Not Applicable

Conditions

Stable Coronary Heart Disease

Interventions

One-catheter concept
Standard catheter

Countries

Germany

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

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Nov 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Oct 18, 2016

First Submission Date that Met QC Criteria

Oct 26, 2016

First Posted Date

Oct 28, 2016Estimated

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

May 14, 2017

Last Update Posted Date

May 16, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Manuel Leistner, MD, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

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

There is no evidence from prospective randomized clinical trials regarding the performance of conventional (two-catheter-concept; TCC) versus one-catheter-concepts (OCC) for invasive coronary angiography over the radial access.

The aim of the present trial is to evaluate the efficacy and safety of different one-catheter concepts by use of the BLK and Tiger catheter compared to a TCC using standard Judkins catheters in diagnostic coronary angiography via transradial access. Patients with stable angina pectoris will be randomly assigned to coronary angiography performed with the BLK or Tiger (OCC) or Judkins catheters (TCC). The primary endpoint is coronary angiography duration.

Detailed Description

The aim of the present trial is to evaluate the efficacy and safety of a one-catheter concept using the BLK (Terumo, Somerset, USA) or the Tiger catheter (Terumo, Somerset, USA) compared to the standard Judkins catheters in diagnostic coronary angiography by the transradial access. Patients with stable angina pectoris will be randomly assigned to coronary angiography performed with the BLK (Group I), Tiger (Group II) or Judkins catheters (Group III). Primary endpoint is the time duration (sec) that is necessary to perform complete coronary angiography including 6 different projections for the left-coronary system and 3 different projections of the right-coronary-system. Secondary endpoints will cover safety and imaging quality of the different catheter systems.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BLK catheter	Experimental	Coronary angiography will be performed with the BLK catheter (one-catheter concept).	Device: One-catheter concept
Tiger catheter	Experimental	Coronary angiography will be performed with the Tiger catheter (one-catheter concept).	Device: One-catheter concept
Judkins catheter	Active Comparator	Coronary angiography will be performed with the Judkins catheter (standard catheter).	Device: Standard catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
One-catheter concept	Device	Coronary angiography will be performed using the one-catheter concept.	BLK catheter Tiger catheter

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Coronary angiography Duration (sec)	assessed by Intention-to-treat analysis (IIT)	Day 0 (corresponding to time point of procedure)

Secondary Outcomes

Measure	Description	Time Frame
Cross over rate to another catheter or transfemoral access.		Day 0 (corresponding to time point of procedure)
Flouroscopy time (sec)		Day 0 (corresponding to time point of procedure)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years and ≤ 95 years
Body weight > 60kg

Exclusion Criteria:

Acute coronary syndrome or cardiogenic shock
Contraindications for transracial access such as absence of radial pulse or abnormal Allen test
Prior unsuccessful transradial coronary angiography
Estimated glomerular filtration rate <40 ml/kg/min
Patients not able to give informed consent
Participation in another trial

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David M Leistner, PD	Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin		Berlin		12203	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided