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

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ClinicalTrials.gov Identifier: NCT03045224
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : February 10, 2017
Sponsor:
Collaborators:
BVMed - The German Medical Technology Association
German Society for Angiology - Society for Vascular Medicine (DGA)
Information provided by (Responsible Party):
Prof. Dr. K.-L. Schulte, Vascular Center Berlin

Brief Summary:
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.

Condition or disease Intervention/treatment
Efficacy/Long-term Effectiveness Endovascular Therapy in PAD Device: PTA, balloon angioplasty, stent

Detailed Description:
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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1760 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Endovascular Treatment in Patients With Peripheral Artery Disease: Real Life Effectiveness Off the Road of Studies PTA-Registry, a Prospective, Multicenter Study With 24-Month Follow-up
Study Start Date : August 2008
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2016



Primary Outcome Measures :
  1. death of any cause [ Time Frame: 2 years ]
  2. revascularization (TLR, TVR) [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. minor or major amputation [ Time Frame: 2 years ]
  2. major adverse cardiac events and stroke [ Time Frame: 2 years ]
  3. quality of life [ Time Frame: 2 years ]
    The follow-up was performed at months 6, 12, 18, and 24. The follow-up consisted of a quality of life questionnaire (EQ-5D)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male and female patients with peripheral arterial disease of the iliac and lower extremity arteries and appropriate clinical indication for treatment with PTA according to current guidelines were included in the registry. Presence of written informed consent for participating in the registry was mandatory. There were no exclusion criteria and no age restriction.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no exclusion criteria and no age restriction

Additional Information:

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Responsible Party: Prof. Dr. K.-L. Schulte, Head of Vascular Center Berlin, Vascular Center Berlin
ClinicalTrials.gov Identifier: NCT03045224    
Other Study ID Numbers: 10PTAReg2016
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. K.-L. Schulte, Vascular Center Berlin:
PAD, PTA, mortality, morbidity, amputation rate, quality of life
Percutaneous transluminal angioplasty (PTA), Stenting, balloon angioplasty