NCT02162082

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

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, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 12, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

4.6 years

First QC Date

June 7, 2014

Last Update Submit

April 25, 2020

Conditions

Coronary Artery DiseaseIschemic Heart DiseaseStable Angina

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events

    1-5 years

Study Arms (1)

stent or scaffold

EXPERIMENTAL

implantation of stents or scaffolds after recanalization of coronary chronic total occlusions

Device: stent or scaffold

Interventions

stent or scaffoldDEVICE

implantation of a CE certified drug-eluting stent, bare-metal stent or scaffold

stent or scaffold

Eligibility Criteria

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

You may qualify if:

  • coronary artery disease
  • chronic total occlusion

You may not qualify if:

  • no written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ulm

Ulm, 89081, Germany

Location

Related Publications (1)

  • 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.

    PMID: 27845998DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial IschemiaAngina, Stable

Interventions

Stents

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Jochen Wöhrle, MD

    University of Ulm, Ulm, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Jochen Wöhrle

Study Record Dates

First Submitted

June 7, 2014

First Posted

June 12, 2014

Study Start

June 1, 2014

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

April 28, 2020

Record last verified: 2020-04

Locations

DE(1)