Coronary and Structural Interventions Ulm - Coronary Chro... | NCT02162082

Studies
Coronary and Structural Interventions Ulm - Coronary Chronic Total Occlusions

NCT02162082

Sponsor

University of Ulm

Status

Completed

Last Update Posted

Apr 28, 2020Actual

Enrollment

198Actual

Phase

Not Applicable

Conditions

Coronary Artery Disease
Ischemic Heart Disease
Stable Angina

Interventions

stent or scaffold

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

Apr 2020

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

Jun 2014

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Jun 7, 2014

First Submission Date that Met QC Criteria

Jun 11, 2014

First Posted Date

Jun 12, 2014Estimated

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

Apr 25, 2020

Last Update Posted Date

Apr 28, 2020Actual

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

To evaluate the long-term results after recanalization of coronary chronic total occlusions.

Detailed Description

Patients with successful recanalization of coronary chronic total occlusions are followed during a period of 5 years to demonstrate safety and efficacy.

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

198Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
stent or scaffold	Experimental	implantation of stents or scaffolds after recanalization of coronary chronic total occlusions	Device: stent or scaffold

Interventions

Name	Type	Description	Arm Group Labels	Other Names
stent or scaffold	Device	implantation of a CE certified drug-eluting stent, bare-metal stent or scaffold	stent or scaffold

Measure	Description	Time Frame
Major adverse cardiac events		1-5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

coronary artery disease
chronic total occlusion

Exclusion Criteria:

no written 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

Name	Affiliation	Role
Jochen Wöhrle, MD	University of Ulm, Ulm, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Ulm		Ulm		89081	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27845998	Derived	Kugler C, Markovic S, Rottbauer W, Wohrle J. Bioresorbable scaffolds compared with everolimus-eluting stents for the treatment of chronic coronary total occlusion: clinical and angiographic results of a matched paired comparison. Coron Artery Dis. 2017 Mar;28(2):120-125. doi: 10.1097/MCA.0000000000000449.

ID	Term
D003324	Coronary Artery Disease
D017202	Myocardial Ischemia
D060050	Angina, Stable

ID	Term
D003327	Coronary Disease
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis

ID	Term
D019736	Prostheses and Implants
D004864	Equipment and Supplies