Efficacy/Long-term Effectiveness Endovascular Therapy in PADPTARegNCT03045224
PTA-Registry, a Prospective, Multicenter Study With 24-Month Follow-up
An observational study of Efficacy/Long-term Effectiveness Endovascular Therapy in PAD, run by Vascular Center Berlin.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Efficacy/Long-term Effectiveness Endovascular Therapy in PAD
- What is being tested?
- PTA, balloon angioplasty, stent
- Type of treatment
- Medical device
- How many people
- 1,760 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Sep 2016
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- peripheral arterial disease of the iliac and lower extremity arteries and appropriate clinical indication for treatment with PTA according to current guidelines
Who cannot join
- no exclusion criteria and no age restriction
About this study
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
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.
Read the 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.
- Being tested
- PTA, balloon angioplasty, stent
- Keywords
- PAD, PTA, mortality, morbidity, amputation rate, quality of life, Percutaneous transluminal angioplasty (PTA), Stenting, balloon angioplasty
- Medical subject headings
- Truncus Arteriosus, Persistent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTA, balloon angioplasty, stentDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
death of any cause
Measured: 2 years
revascularization (TLR, TVR)
Measured: 2 years
Secondary outcomes (3)
minor or major amputation
Measured: 2 years
major adverse cardiac events and stroke
Measured: 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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study startAug 2008
- Primary completionAug 2014
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy/Long-term Effectiveness Endovascular Therapy in PADStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,760 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Vascular Center Berlin
- Sponsor type
- University, hospital or other
- Collaborators
- BVMed - The German Medical Technology Association, German Society for Angiology - Society for Vascular Medicine (DGA)
- Responsible party
- Principal investigator, Prof. Dr. K.-L. Schulte, Vascular Center Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045224
- Sponsor's protocol ID
- 10PTAReg2016
- Acronym
- PTAReg
- Status last verified
- Feb 2017
- First submitted
- 3 Feb 2017
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03045224
- Acronym / sponsor ID
- PTAReg / 10PTAReg2016
- Keywords
- PAD, PTA, mortality, morbidity, amputation rate, quality of life, Percutaneous transluminal angioplasty (PTA), Stenting, balloon angioplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,760 participants (actual)
- Lead sponsor
- Vascular Center BerlinUniversity, hospital or other
- Collaborators
- BVMed - The German Medical Technology Association, German Society for Angiology - Society for Vascular Medicine (DGA)
- Study start
- Aug 2008
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- peripheral arterial disease of the iliac and lower extremity arteries and appropriate clinical indication for treatment with PTA according to current guidelines
Key exclusion criteria (1 listed)
- no exclusion criteria and no age restriction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTA, balloon angioplasty, stent | Device | – |
Primary outcome
death of any cause
Time frame: 2 years
revascularization (TLR, TVR)
Time frame: 2 years
3 secondary outcomes
minor or major amputation
Time frame: 2 years
major adverse cardiac events and stroke
Time frame: 2 years
quality of life
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Efficacy/Long-term Effectiveness Endovascular Therapy in PAD, run by Vascular Center Berlin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death of any cause (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017.