StenosisPhase 3ConSeQuentNCT01970579
Clinical Trial on Peripheral Arteries Treated With SeQuent® Please P Paclitaxel Coated Balloon Catheter
A Phase 3 study testing Paclitaxel coated balloon and uncoated PTA catheter in people with Stenosis and Restenosis, run by B. Braun Melsungen AG at 7 sites in Germany.
Trial summary
The aim of the study is to assess the safety and efficacy of the paclitaxelreleasing balloon catheter SeQuent® Please P to treat de novo and restenotic lesions in the superficial femoral artery and the proximal two segments of the popliteal artery with reference diameters ≥ 4mm \& ≤ 7mm and lesion lengths ≥ 4 cm \& ≤… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stenosis, Restenosis
- What is being tested?
- Paclitaxel coated balloon and uncoated PTA catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 7 sitesGermany
- Study dates
- Oct 2013to Dec 2019
- Phase
- Phase 3
- 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
Who may be able to join
- Willingness to treat the target lesion according to the DCB only concept
- Patients in Rutherford classes 2 through 4 (corresponding to Fontaine stage IIb to III)
- Patients eligible for peripheral revascularization by means of 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 following the study protocol
- Patients must agree to undergo the 6-month angiographic and clinical follow-up
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- Patients must agree to undergo the 1 and 2 year clinical follow-up
- Patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial. The patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document.
- Peripheral lesions in the native SFA or popliteal artery with reference vessel diameters between ≥ 4.0 and ≤ 7.0 mm, lesions lengths ≥ 4 cm and ≤ 27 cm as angiographically documented
- Diameter stenosis pre-procedure must be ≥ 70%
- Target lesion in the SFA or popliteal artery (first two proximal segments)*.
- as far as applicable distance of the target lesion to a previously implanted stent should be about 1cm
- Vessels must have adequate runoff with at least one vessel to the foot.
- Treatment of max. two lesions is permitted.
Who cannot join
- Patients with Rutherford class 5 or 6
- Women who are known or suspected to be pregnant. Hence, patients will be advised to use an adequate birth control method up to and including the 6-month follow-up.
- Patients with an expected life span of less than 24 months
- Patients with bleeding diathesis in whom anticoagulation or anti-platelet medication is contraindicated
- Patients who had a cerebral stroke < 6 months prior to the procedure
- Patients with unstable angina pectoris
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- Patients with acute myocardial infarction within the past 2 weeks
- Patient participates in other clinical trials involving any investigational device or drug that interfere with the effects to be studied in this trial.
- Interventional treatment at the contralateral leg within 2 weeks prior to or after the study intervention
- Untreated hyperthyroidism
- Patient has presence or history of severe renal failure (GFR < 30ml/min) and is therefore not eligible for angiography.
- Post transplantation of any organ or immune suppressive medication
- Other disease to jeopardize follow-up (e.g. malignoma)
- Addiction to any drug or to alcohol (WHO definition)
- Patients with clinically significant aneurysmal disease of the popliteal, femoral or iliac artery and patients with history of clinically significant abdominal aortic aneurysm
- Patients with any type of surgical/interventional procedures within 4 weeks prior to or planned after study intervention (if those may interfere with the peripheral study intervention and/or patient's ability to perform the follow up examinations)
- Conditions which prevent the intake of the double anti-platelet therapy for two months
- Patients with contraindication for drug-eluting balloon angioplasty given in the instruction for use
- Patients under administrative or judicial custody (§20 Act on Medical Devices, Germany)
- Strongly calcified lesions with circumferential presence of calcifications and a lesion length of > 4 cm
- Chronic total occlusions longer than 10 cm
- Lesion below the knee requiring treatment
- Target lesion within a bypass graft
- In-stent restenosis
- Lesions treated with DCB
- Concomitant use of atherectomy, cryoplasty or laser therapy
- Inflow lesion (proximal to the study lesion) with flow limitation not being successfully treated prior to the study lesion
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, 79189
Vivantes Klinikum Neukölln
Berlin, 12351
Ev. Krankenhaus Hubertus
Berlin, 14129
Klinikum der Otto-von-Guericke-Universität Magdeburg
Magdeburg, 39120
Klinikum Magdeburg
Magdeburg, 39130
Deutsches Herzzentrum München
München, 80636
RoMed Klinikum Rosenheim
Rosenheim, 83022
About this study
The aim of the study is to assess the safety and efficacy of the paclitaxelreleasing balloon catheter SeQuent® Please P to treat de novo and restenotic lesions in the superficial femoral artery and the proximal two segments of the popliteal artery with reference diameters ≥ 4mm \& ≤ 7mm and lesion lengths ≥ 4 cm \& ≤ 27 cm. It is the intention of this trial to treat suitable target lesions with DCB only.
- Conditions
- Stenosis, Restenosis
- Being tested
- Paclitaxel coated balloon, uncoated PTA catheter
- Medical subject headings
- Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel coated balloonDevice
Also called SeQuent® Please P, Drug coated balloon
- Treatment of target lesion with study balloon (coated). Diameter of treatment balloon = RVD
- Each study balloon must only be used once (except postdilatation is necessary which may be done with the same balloon used for the initial dilatation)
- Treatment balloon must be 20 mm longer than lesion length (to assure balloon overlap of 10 mm proximal and distal to lesion)
- If two treatment balloons are necessary overlap between the balloon must be 10 mm
- Inflation pressure 7-10 atm
- Intraluminal defects or haziness should be treated with additional inflations and/or aggressive anti-platelet agents or bailout stenting
uncoated PTA catheterDevice
Also called POBA
- Treatment of target lesion with study balloon (uncoated). Diameter of treatment balloon = RVD
- Each study balloon must only be used once (except postdilatation is necessary which may be done with the same balloon used for the initial dilatation)
- Treatment balloon must be 20 mm longer than lesion length (to assure balloon overlap of 10 mm proximal and distal to lesion)
- If two treatment balloons are necessary overlap between the balloon must be 10 mm
- Inflation pressure 7-10 atm
- Intraluminal defects or haziness should be treated with additional inflations and/or aggressive anti-platelet agents or bailout stenting.
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel coated balloon | Experimental | Not described Receives: Device: Paclitaxel coated balloon |
| uncoated PTA catheter | Active comparator | Not described Receives: Device: uncoated PTA catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late Lumen Loss
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2015
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StenosisStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Albrecht, MD, Principal investigator, Vivantes Klinikum Neukölln, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970579
- Sponsor's protocol ID
- AAG-G-H-1214
- Acronym
- ConSeQuent
- Status last verified
- Mar 2020
- First submitted
- 23 Oct 2013
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
PubMed 42573020Albrecht T, Waliszewski M, Roca C, Redlich U, Tautenhahn J, Pech M, Halloul Z, Gogebakan O, Meyer DR, Gemeinhardt I, Zeller T, Muller-Hulsbeck S, Ott I, Tepe G. Two-Year Clinical Outcomes of the CONSEQUENT Trial: Can Femoropopliteal Lesions be Treated with Sustainable Clinical Results that are Economically Sound? Cardiovasc Intervent Radiol. 2018 Jul;41(7):1008-1014. doi: 10.1007/s00270-018-1940-1. Epub 2018 Mar 27.
PubMed 29589098Tepe G, Gogebakan O, Redlich U, Tautenhahn J, Ricke J, Halloul Z, Meyer DR, Waliszewski M, Schnorr B, Zeller T, Muller-Hulsbeck S, Ott I, Albrecht T. Angiographic and Clinical Outcomes After Treatment of Femoro-Popliteal Lesions with a Novel Paclitaxel-Matrix-Coated Balloon Catheter. Cardiovasc Intervent Radiol. 2017 Oct;40(10):1535-1544. doi: 10.1007/s00270-017-1713-2. Epub 2017 Jun 28.
PubMed 28660441
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on Peripheral Arteries Treated With SeQuent® Please P Paclitaxel Coated Balloon Catheter
- ClinicalTrials.gov ID
- NCT01970579
- Acronym / sponsor ID
- ConSeQuent / AAG-G-H-1214
- Conditions
- Stenosis, Restenosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 28 Oct 2013 (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 paclitaxelreleasing balloon catheter SeQuent® Please P to treat de novo and restenotic lesions in the superficial femoral artery and the proximal two segments of the popliteal artery with reference diameters ≥ 4mm \& ≤ 7mm and lesion lengths ≥ 4 cm \& ≤ 27 cm. It is the intention of this trial to treat suitable target lesions with DCB only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel coated balloon | Experimental | Device: Paclitaxel coated balloon |
| uncoated PTA catheter | Active comparator | Device: uncoated PTA catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Willingness to treat the target lesion according to the DCB only concept
- Patients in Rutherford classes 2 through 4 (corresponding to Fontaine stage IIb to III)
- Patients eligible for peripheral revascularization by means of 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 following the study protocol
Key exclusion criteria (27 listed)
- Patients with Rutherford class 5 or 6
- Women who are known or suspected to be pregnant. Hence, patients will be advised to use an adequate birth control method up to and including the 6-month follow-up.
- Patients with an expected life span of less than 24 months
- Patients with bleeding diathesis in whom anticoagulation or anti-platelet medication is contraindicated
- Patients who had a cerebral stroke < 6 months prior to the procedure
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 |
|---|---|---|
| Paclitaxel coated balloonAlso: SeQuent® Please P, Drug coated balloon* Treatment of target lesion with study balloon (coated). Diameter of treatment balloon = RVD * Each study balloon must only be used once (except postdilatation is necessary which may be done with the same balloon used for the initial dilatation) * Treatment balloon must be 20 mm longer than lesion length (to assure balloon overlap of 10 mm proximal and distal to lesion) * If two treatment balloons are necessary overlap between the balloon must be 10 mm * Inflation pressure 7-10 atm * Intraluminal defects or haziness should be treated with additional inflations and/or aggressive anti-platelet agents or bailout stenting | Device | Paclitaxel coated balloon |
| uncoated PTA catheterAlso: POBA* Treatment of target lesion with study balloon (uncoated). Diameter of treatment balloon = RVD * Each study balloon must only be used once (except postdilatation is necessary which may be done with the same balloon used for the initial dilatation) * Treatment balloon must be 20 mm longer than lesion length (to assure balloon overlap of 10 mm proximal and distal to lesion) * If two treatment balloons are necessary overlap between the balloon must be 10 mm * Inflation pressure 7-10 atm * Intraluminal defects or haziness should be treated with additional inflations and/or aggressive anti-platelet agents or bailout stenting. | Device | uncoated PTA catheter |
Primary outcome
Late Lumen Loss
Time frame: 6 months
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 30 Mar 2020.
- Derived from this study: PubMed 42573020Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
- Derived from this study: PubMed 29589098Albrecht T, Waliszewski M, Roca C, Redlich U, Tautenhahn J, Pech M, Halloul Z, Gogebakan O, Meyer DR, Gemeinhardt I, Zeller T, Muller-Hulsbeck S, Ott I, Tepe G. Two-Year Clinical Outcomes of the CONSEQUENT Trial: Can Femoropopliteal Lesions be Treated with Sustainable Clinical Results that are Economically Sound? Cardiovasc Intervent Radiol. 2018 Jul;41(7):1008-1014. doi: 10.1007/s00270-018-1940-1. Epub 2018 Mar 27.
- Derived from this study: PubMed 28660441Tepe G, Gogebakan O, Redlich U, Tautenhahn J, Ricke J, Halloul Z, Meyer DR, Waliszewski M, Schnorr B, Zeller T, Muller-Hulsbeck S, Ott I, Albrecht T. Angiographic and Clinical Outcomes After Treatment of Femoro-Popliteal Lesions with a Novel Paclitaxel-Matrix-Coated Balloon Catheter. Cardiovasc Intervent Radiol. 2017 Oct;40(10):1535-1544. doi: 10.1007/s00270-017-1713-2. Epub 2017 Jun 28.
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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.
Thomas Albrecht, MD principal investigator
Vivantes Klinikum Neukölln, Berlin, Germany
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paclitaxel coated balloon and uncoated PTA catheter in people with Stenosis and Restenosis, run by B. Braun Melsungen AG at 7 sites 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 14 inclusion and 27 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 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Late Lumen Loss (time frame: 6 months). 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 NCT01970579, which also lists 3 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 30 Mar 2020.