Coronary and Structural Interventions Ulm - Bioresorbable Vascular Scaffold

NCT ID: NCT02162056

Last Updated: 2020-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2018-12-31

Brief Summary

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To evaluate the safety, performance and efficacy of the bioresorbable vascular scaffold (BVS) system in patients with coronary artery disease

Detailed Description

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Patients with coronary artery disease receive bioabsorbable vascular scaffolds. Patients are clinically followed during a period of 10 years.

Conditions

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Coronary Artery Disease Ischemic Heart Disease Stable Angina Unstable Angina Acute Myocardial Infarction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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use of bioresorbable vascular scaffolds

Implantation of bioresorbable vascular scaffold for coronary artery disease.

Group Type EXPERIMENTAL

use of bioresorbable vascular scaffolds

Intervention Type DEVICE

Implantation of bioresorbable vascular scaffolds for coronary artery disease.

Interventions

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use of bioresorbable vascular scaffolds

Implantation of bioresorbable vascular scaffolds for coronary artery disease.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* coronary artery disease
* implantation of at least one bioresorbable vascular scaffold

Exclusion Criteria

* no written informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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Jochen Wohrle

Prof. Dr. Jochen Wöhrle

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jochen Wöhrle, MD

Role: PRINCIPAL_INVESTIGATOR

University of Ulm, Ulm, Germany

Locations

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University of Ulm

Ulm, , Germany

Site Status

Countries

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Germany

References

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Reichart C, Wohrle J, Markovic S, Rottbauer W, Seeger J. Clinical results of bioresorbable drug-eluting scaffolds in short and long coronary artery lesions using the PSP technique. BMC Cardiovasc Disord. 2019 Jan 18;19(1):22. doi: 10.1186/s12872-018-0994-y.

Reference Type RESULT
PMID: 30658574 (View on PubMed)

Markovic S, Kugler C, Rottbauer W, Wohrle J. Long-term clinical results of bioresorbable absorb scaffolds using the PSP-technique in patients with and without diabetes. J Interv Cardiol. 2017 Aug;30(4):325-330. doi: 10.1111/joic.12392. Epub 2017 Jun 1.

Reference Type DERIVED
PMID: 28568564 (View on PubMed)

Markovic S, Dragomir S, Walcher D, Bernhardt P, Imhof A, Rottbauer W, Wohrle J. Clinical results of single and multiple bioresorbable drug-eluting scaffolds for treatment of de-novo coronary artery disease. Coron Artery Dis. 2016 Nov;27(7):561-5. doi: 10.1097/MCA.0000000000000392.

Reference Type DERIVED
PMID: 27244371 (View on PubMed)

Other Identifiers

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CSI-Ulm-BVS 1.0

Identifier Type: -

Identifier Source: org_study_id

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