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

Efficacy/Long-term Effectiveness Endovascular Therapy in PAD Clinical Trial

— PTAReg  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03045224
• Other study ID #: 10PTAReg2016
• Status: Completed
• Phase: N/A
• First received: February 3, 2017
• Last updated: February 7, 2017
• Start date: August 2008
• Est. completion date: September 2016

Study information

• Verified date: February 2017
• Source: Vascular Center Berlin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1760
• Est. completion date: September 2016
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Efficacy/Long-term Effectiveness Endovascular Therapy in PAD

Intervention

Device:
• PTA, balloon angioplasty, stent

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Vascular Center Berlin	BVMed - The German Medical Technology Association, German Society of Angiology/Society of Vascular Medicine (DGA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death of any cause		2 years
Primary	revascularization (TLR, TVR)		2 years
Secondary	minor or major amputation		2 years
Secondary	major adverse cardiac events and stroke		2 years
Secondary	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