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

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

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.

Study Overview

• Status: Completed
• Conditions: Efficacy/Long-term Effectiveness Endovascular Therapy in PAD
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 1760

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
death of any cause	2 years
revascularization (TLR, TVR)	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vascular Center Berlin
• Collaborators: BVMed - The German Medical Technology Association; German Society for Angiology - Society for Vascular Medicine (DGA)

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: February 3, 2017
• First Submitted That Met QC Criteria: February 3, 2017
• First Posted (ESTIMATE): February 7, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: PAD, PTA, mortality, morbidity, amputation rate, quality of life; Percutaneous transluminal angioplasty (PTA), Stenting, balloon angioplasty
• Other Study ID Numbers: 10PTAReg2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No