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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02739685
Other study ID # 15-373
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date January 2017

Study information

Verified date September 2019
Source University of Luebeck
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the current study is to demonstrate non-inferiority of everolimus-eluting bioresorbable vascular scaffold to everolimus-eluting stents in patients with chronic total occlusion regarding the antirestenotic efficacy at 8 to 10-month angiographic follow-up.


Recruitment information / eligibility

Status Terminated
Enrollment 17
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Clinical inclusion criteria:

- Age =18 years

- Angina pectoris, equivalent symptoms, and/or positive stress test

- Viable myocardium subtended by chronic total occlusion

- Negative pregnancy test in women with childbearing potential

Angiographic inclusion criteria:

- Chronic total occlusion defined as Thrombolysis in Myocardial Infarction flow 0 with an estimated duration =3 months

- Successful wire passage and assumption of successful stent/scaffold deployment

- Target reference vessel diameter 2.5 - 4.0 mm

Exclusion Criteria:

Clinical exclusion criteria:

- Limited long-term prognosis with a life-expectancy <12 months

- Contraindications to antiplatelet therapy

- Known allergy against cobalt chrome, everolimus, or polylactic acid

Angiographic exclusion criteria:

- Target lesion located in the left main trunk

- Target lesion located in a coronary bypass graft

- Bifurcation lesion with planned two-stent strategy

- Indication for coronary artery bypass grafting

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Everolimus-eluting bioresorbable vascular scaffold
Implantation of everolimus-eluting bioresorbable vascular scaffold in chronic total occlusion
Everolimus-eluting stent
Implantation of everolimus-eluting stent in chronic total occlusion

Locations

Country Name City State
Germany University of Luebeck Luebeck

Sponsors (1)

Lead Sponsor Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary In-stent late lumen loss assessed by angiography 8-10 months after the index procedure
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