An observational study in Peripheral Arterial Occlusive Disease, sponsored by B. Braun Melsungen AG. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by B. Braun Melsungen AG · Observational
The aim of the study is to assess the safety and efficacy of the paclitaxel-releasing balloon catheter SeQuent® Please OTW to treat de novo and restenotic lesions in peripheral arteries. It is the intention of this trial to treat suitable target lesions with drug coated balloon (DCB) only.
This study is an non-randomized, prospective, multi-center, non-interventional study (NIS=registry, for Germany: §23b MPG)
B. Braun Melsungen AG is the lead sponsor of 47 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with peripheral artery occlusive disease (PAOD)
Inclusion Criteria (patient):
Inclusion Criteria (lesion):
Exclusion Criteria (all comers):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
percutaneous transluminal angioplasty with peripheral balloon catheters
Also known as: peripheral drug eluting balloon
Target Lesion Revascularization Rate
rate of target lesion revascularization (interventional, surgical)
Time frame: 12 months
Target Lesion Revascularization Rate (TLR)
Target Lesion Revascularization Rate at 24 months\* to establish a 'freedom from TLR' Kaplan-Meier curve
Time frame: 24 months
Procedural success
Procedural success to pass and treat the lesions (remaining stenosis is 30 %)
Time frame: 1 day
Ankle Brachial Index (ABI)
ankle brachial index
Time frame: 12 months
Ankle Brachial Index (ABI)
ankle brachial index
Time frame: 24 months
Ankle Brachial Index (ABI)
ankle brachial index
Time frame: 3 years
Ankle Brachial Index (ABI)
ankle brachial index
Time frame: 5 years
Maximum Walking Distance (MWD)
maximum walking distance under standardized conditions
Time frame: 12 months
Maximum Walking Distance (MWD)
maximum walking distance under standardized conditions
Time frame: 24 months
Maximum Walking Distance (MWD)
maximum walking distance under standardized conditions
Time frame: 3 years
Maximum Walking Distance (MWD)
maximum walking distance under standardized conditions
Time frame: 5 years
Patency rate
Patency rates as observed using non-invasive Duplex ultrasound
Time frame: 12 months
Patency rate
Patency rates as observed using non-invasive Duplex ultrasound
Time frame: 24 months
Patency rate
Patency rates as observed using non-invasive Duplex ultrasound
Time frame: 3 years
Patency rate
Patency rates as observed using non-invasive Duplex ultrasound
Time frame: 5 years
Rutherford classifications per group at all follow-up intervals
Rutherford classifications per group at all follow-up intervals
Time frame: 12/24 months and 3/5 years
Rutherford classification distribution change at all follow-up intervals
Rutherford classification distribution change at all follow-up intervals
Time frame: 12/24 months and 3/5 years
Amputation rate
Amputation rate at 12/24 months and 3/5 years and 'freedom from amputation' Kaplan-Meier curve
Time frame: 12/24 months and 3/5 years
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from May 2015 to primary completion in Dec 2018, 43 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Peripheral Arterial Occlusive Disease 1