PTA-Registry, a Prospective, Multicenter Study With 24-Month Follow-up

NCT ID: NCT03045224

Last Updated: 2017-02-09

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

Total Enrollment

1760 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2016-09-30

Brief Summary

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The PTA-Registry (PTA-REG) is a prospective health services research registry to monitor and follow-up patients with peripheral arterial disease undergoing endovascular peripheral intervention. The PTA-REG has an interdisciplinary approach: cardiologists, angiologists, and radiologists contributed actively to this registry.

Detailed Description

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The registry was created for the following purposes: evaluation of the clinical effectiveness, safety and quality of the endovascular therapy, and history of the disease after endovascular therapy. The resulting specific research questions were determination of the technical and clinical success of the procedure, monitoring of periinterventional complications, evaluation of vessel patency, amputation rate, mortality, and major adverse cardiac events during the follow-up. In addition, the quality of life after endovascular peripheral intervention over a period of two years was evaluated.

Conditions

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Efficacy/Long-term Effectiveness Endovascular Therapy in PAD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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PTA, balloon angioplasty, stent

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* peripheral arterial disease of the iliac and lower extremity arteries and appropriate clinical indication for treatment with PTA according to current guidelines
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BVMed - The German Medical Technology Association

UNKNOWN

Sponsor Role collaborator

German Society for Angiology - Society for Vascular Medicine (DGA)

OTHER

Sponsor Role collaborator

Vascular Center Berlin

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. K.-L. Schulte

Head of Vascular Center Berlin

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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10PTAReg2016

Identifier Type: -

Identifier Source: org_study_id

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