Percutaneous Transluminal AngioplastyNCT02728479
Percutaneous Transluminal Angioplasty Registry
An observational study of Percutaneous Transluminal Angioplasty, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
Trial summary
Percutaneous transluminal angioplasty (PTA) is a minimally invasive procedure for dilating blood vessels in the treatment of peripheral artery disease. The aim of this registry is to collect prospectively and systematically clinical research data from patients undergoing PTA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Transluminal Angioplasty
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Jan 2030
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients undergoing PTA
Who may be able to join
- Patients undergoing PTA
Who cannot join
- < 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
Christian Heiss, MD
Yvonne Heinen, MD
About this study
Official title: PTA Registry - an Observational Study of Percutaneous Transluminal Angioplasty
Percutaneous transluminal angioplasty (PTA) is a minimally invasive procedure for dilating blood vessels in the treatment of peripheral artery disease.
The aim of this registry is to collect prospectively and systematically clinical research data from patients undergoing PTA. This registry is an open-end observational study to assess the characteristics and outcomes in patients with undergoing PTA.
- Conditions
- Percutaneous Transluminal Angioplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency rate
Measured: 6 months
Creatinine level
Measured: 2 Days after PTA
Secondary outcomes (5)
Mortality
Measured: 30 days
Days of Hospitalization
Days of Hospitalization at 12 months
Measured: 12 months
Ankle-Brachial Index
Clinical Improvement measured by Ankle-Brachial Index
Measured: 6 months and 12 months
walking distance
Clinical Improvement measured by walking distance
Measured: 6 months and 12 months
Restenosis rate
Percentage of patients with restenosis at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Transluminal AngioplastyStudies 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
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Christian Heiss, MD, Principal investigator, Division of Cardiology, Pulmonary Disease and Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728479
- Sponsor's protocol ID
- PTA Registry
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2016
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Baasen S, Stern M, Wischmann P, Schremmer J, Sansone R, Spieker M, Wolff G, Bonner F, Quast C, Heiss C, Kelm M, Busch L. Endovascular Treatment of Flow-Limiting Iliofemoral Stenosis Improves Left Ventricular Diastolic Function in Patients With HFpEF by Reducing Aortic Pulsatile Load. Circ Heart Fail. 2024 Sep;17(9):e011258. doi: 10.1161/CIRCHEARTFAILURE.123.011258. Epub 2024 Sep 9.
PubMed 39247971Busch L, Heinen Y, Stern M, Wolff G, Ozaslan G, Tzetou K, Sansone R, Heiss C, Kelm M. Angioplasty of Flow-Limiting Stenosis Reduces Aortic and Brachial Blood Pressure in Patients With Peripheral Artery Disease. J Am Heart Assoc. 2021 Jul 20;10(14):e019724. doi: 10.1161/JAHA.120.019724. Epub 2021 Jul 6.
PubMed 34227407
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PTA Registry - an Observational Study of Percutaneous Transluminal Angioplasty
- ClinicalTrials.gov ID
- NCT02728479
- Acronym / sponsor ID
- PTA Registry
- Conditions
- Percutaneous Transluminal Angioplasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und AngiologieUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 5 Apr 2016 (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.
Percutaneous transluminal angioplasty (PTA) is a minimally invasive procedure for dilating blood vessels in the treatment of peripheral artery disease.
The aim of this registry is to collect prospectively and systematically clinical research data from patients undergoing PTA. This registry is an open-end observational study to assess the characteristics and outcomes in patients with undergoing PTA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing PTA
Key inclusion criteria (1 listed)
- Patients undergoing PTA
Key exclusion criteria (1 listed)
- < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patency rate
Time frame: 6 months
Creatinine level
Time frame: 2 Days after PTA
5 secondary outcomes
Mortality
Time frame: 30 days
Days of Hospitalization
Time frame: 12 months
Ankle-Brachial Index
Time frame: 6 months and 12 months
walking distance
Time frame: 6 months and 12 months
Restenosis rate
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Derived from this study: PubMed 39247971Baasen S, Stern M, Wischmann P, Schremmer J, Sansone R, Spieker M, Wolff G, Bonner F, Quast C, Heiss C, Kelm M, Busch L. Endovascular Treatment of Flow-Limiting Iliofemoral Stenosis Improves Left Ventricular Diastolic Function in Patients With HFpEF by Reducing Aortic Pulsatile Load. Circ Heart Fail. 2024 Sep;17(9):e011258. doi: 10.1161/CIRCHEARTFAILURE.123.011258. Epub 2024 Sep 9.
- Derived from this study: PubMed 34227407Busch L, Heinen Y, Stern M, Wolff G, Ozaslan G, Tzetou K, Sansone R, Heiss C, Kelm M. Angioplasty of Flow-Limiting Stenosis Reduces Aortic and Brachial Blood Pressure in Patients With Peripheral Artery Disease. J Am Heart Assoc. 2021 Jul 20;10(14):e019724. doi: 10.1161/JAHA.120.019724. Epub 2021 Jul 6.
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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.
Christian Heiss, MD principal investigator
Division of Cardiology, Pulmonary Disease and Vascular Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Transluminal Angioplasty, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
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: looking for participants now, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Heiss, MD (+49 211 8118800, christian.heiss@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patency rate (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT02728479, which also lists 2 linked publications.
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 7 Feb 2020.