Peripheral Arterial Occlusive DiseaseCONSEQUENTNCT02460042
Clinical Post Market Clinical Follow-up (PMCF) on Peripheral Arteries Treated With SeQuent® Please Over The Wire (OTW)
An observational study of Peripheral Arterial Occlusive Disease, run by B. Braun Melsungen AG at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Occlusive Disease
- What is being tested?
- drug coated balloon angioplasty and SeQuent® Please OTW Paclitaxel Coated Balloon Catheter
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 960 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to 19 Nov 2025
- 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: Patients with peripheral artery occlusive disease (PAOD)
Who may be able to join
- Willingness to treat the target lesion according to the DCB only concept
- Patients in Rutherford classes 2 through 5
- Patients eligible for peripheral revascularization by means of Percutaneous Transluminal Angioplasty (PTA)
- Patients must be 18 years of age
- Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in the following study protocol
- Patients must agree to undergo at least the 12-month clinical follow-up
Show all 11Show fewer
- Patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial, e.g. balloon angioplasty by means of the paclitaxel-eluting PTA-balloon catheter or other suitable devices. Patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document.
- Peripheral lesions in peripheral arteries above and below the knee with reference vessel diameters between 1.5 and 8.0 mm, lesion lengths ≥ 2 cm and ≤ 27 cm as angiographically documented*
- Diameter stenosis pre-procedure must be 70%
- Target lesion above and below the knee
- Vessels must have adequate runoff with at least one vessel to the foot. *Lesions separated by less than 2 cm are considered as one lesion
Who cannot join
- Patient not suitable for revascularization by interventional means
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CONSEQUENT ALL COMERS Clinical PMCF on Peripheral Arteries Treated With SeQuent® Please OTW Paclitaxel Coated Balloon Catheter in an All Comer Patient Population
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.
Read the detailed description
This study is an non-randomized, prospective, multi-center, non-interventional study (NIS=registry, for Germany: §23b MPG)
- Conditions
- Peripheral Arterial Occlusive Disease
- Being tested
- drug coated balloon angioplasty, SeQuent® Please OTW Paclitaxel Coated Balloon Catheter
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug coated balloon angioplastyProcedure or surgery
Also called peripheral drug eluting balloon
percutaneous transluminal angioplasty with peripheral balloon catheters
SeQuent® Please OTW Paclitaxel Coated Balloon CatheterDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Revascularization Rate
rate of target lesion revascularization (interventional, surgical)
Measured: 12 months
Secondary outcomes (17)
Target Lesion Revascularization Rate (TLR)
Target Lesion Revascularization Rate at 24 months* to establish a 'freedom from TLR' Kaplan-Meier curve
Measured: 24 months
Procedural success
Procedural success to pass and treat the lesions (remaining stenosis is 30 %)
Measured: 1 day
Ankle Brachial Index (ABI)
ankle brachial index
Measured: 12 months
Ankle Brachial Index (ABI)
ankle brachial index
Measured: 24 months
Ankle Brachial Index (ABI)
ankle brachial index
Measured: 3 years
Ankle Brachial Index (ABI)
ankle brachial index
Measured: 5 years
Maximum Walking Distance (MWD)
maximum walking distance under standardized conditions
Measured: 12 months
Maximum Walking Distance (MWD)
maximum walking distance under standardized conditions
Measured: 24 months
Maximum Walking Distance (MWD)
maximum walking distance under standardized conditions
Measured: 3 years
Maximum Walking Distance (MWD)
maximum walking distance under standardized conditions
Measured: 5 years
Patency rate
Patency rates as observed using non-invasive Duplex ultrasound
Measured: 12 months
Patency rate
Patency rates as observed using non-invasive Duplex ultrasound
Measured: 24 months
Patency rate
Patency rates as observed using non-invasive Duplex ultrasound
Measured: 3 years
Patency rate
Patency rates as observed using non-invasive Duplex ultrasound
Measured: 5 years
Rutherford classifications per group at all follow-up intervals
Rutherford classifications per group at all follow-up intervals
Measured: 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
Measured: 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
Measured: 12/24 months and 3/5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2018
- Study completion19 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Occlusive DiseaseStudies 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
- 960 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralf Langhoff, MD, Principal investigator, St. Gertrauden Krankenhaus, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460042
- Sponsor's protocol ID
- AAG-O-H-1309
- Acronym
- CONSEQUENT
- Status last verified
- Jul 2026
- First submitted
- 26 Feb 2015
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONSEQUENT ALL COMERS Clinical PMCF on Peripheral Arteries Treated With SeQuent® Please OTW Paclitaxel Coated Balloon Catheter in an All Comer Patient Population
- ClinicalTrials.gov ID
- NCT02460042
- Acronym / sponsor ID
- CONSEQUENT / AAG-O-H-1309
- Conditions
- Peripheral Arterial Occlusive Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 960 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- 19 Nov 2025 (actual)
- First posted
- 2 Jun 2015 (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 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.
Detailed description
This study is an non-randomized, prospective, multi-center, non-interventional study (NIS=registry, for Germany: §23b MPG)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with peripheral artery occlusive disease (PAOD)
Key inclusion criteria (11 listed)
- Willingness to treat the target lesion according to the DCB only concept
- Patients in Rutherford classes 2 through 5
- Patients eligible for peripheral revascularization by means of Percutaneous Transluminal Angioplasty (PTA)
- Patients must be 18 years of age
- Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in the following study protocol
Key exclusion criteria (1 listed)
- Patient not suitable for revascularization by interventional means
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 |
|---|---|---|
| drug coated balloon angioplastyAlso: peripheral drug eluting balloonpercutaneous transluminal angioplasty with peripheral balloon catheters | Procedure or surgery | – |
| SeQuent® Please OTW Paclitaxel Coated Balloon Catheter | Device | – |
Primary outcome
Target Lesion Revascularization Rate
Time frame: 12 months
rate of target lesion revascularization (interventional, surgical)
17 secondary outcomes
Target Lesion Revascularization Rate (TLR)
Time frame: 24 months
Procedural success
Time frame: 1 day
Ankle Brachial Index (ABI)
Time frame: 12 months
Ankle Brachial Index (ABI)
Time frame: 24 months
Ankle Brachial Index (ABI)
Time frame: 3 years
Ankle Brachial Index (ABI)
Time frame: 5 years
Maximum Walking Distance (MWD)
Time frame: 12 months
Maximum Walking Distance (MWD)
Time frame: 24 months
Maximum Walking Distance (MWD)
Time frame: 3 years
Maximum Walking Distance (MWD)
Time frame: 5 years
Patency rate
Time frame: 12 months
Patency rate
Time frame: 24 months
Patency rate
Time frame: 3 years
Patency rate
Time frame: 5 years
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
Time frame: 12/24 months and 3/5 years
Amputation rate
Time frame: 12/24 months and 3/5 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 16 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Ralf Langhoff, MD principal investigator
St. Gertrauden Krankenhaus, Berlin, Germany
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 Peripheral Arterial Occlusive Disease, run by B. Braun Melsungen AG 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 11 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 16 Jul 2026. 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?
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?
Target Lesion Revascularization Rate (time frame: 12 months). 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 16 Jul 2026.