StenosisSPORTSNCT03332264
Sequent Please Drug Coated Balloons Versus Primary Stent Application in Long SFA Lesions
A study testing SeQuent Please OTW, Eluvia Vascular Stent System and Nitinol stent in people with Stenosis and Occlusion, run by InnoRa GmbH at 10 sites in 2 countries.
Trial summary
Patients with peripheral artery disease will be treated with either drug coated balloon catheter, drug coated stent or uncoated stent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stenosis, Occlusion, Restenosis
- What is being tested?
- SeQuent Please OTW, Eluvia Vascular Stent System and Nitinol stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 30 Mar 2017to 12 Dec 2023
- Phase
- Interventional
- 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
- PAOD and Rutherford classes 2 - 4 (pain-free walking distance <500 m)
- eligible for peripheral revascularization by means of PTA
- peripheral lesions in the superficial femoral artery (SFA) and / or the PI-segment of the popliteal artery (A.pop.)
- minimum diameter stenosis of ≥70%
- treatment length at least 15 cm (lesion length at least 13 cm)
- maximum of lesions to be treated should be 2 (all treated lesions should be treated within the randomization to the study group, i.e. either coated balloon catheters or coated stents or bare nitinol stents); in case of two lesions matching the eligibility criteria, the one presenting the worst attributes (length and stenosis degree) should be chosen as target lesion
- long diffuse stenosis with or without occlusions may only be divided in separate lesions if non-stenotic (i.e. <50% stenosis) segments in between the lesions extent to >2 cm, otherwise vessel segments will be treated as a single extended lesion
- eligible for an operative vascular intervention in case of complications during the PTA
Who cannot join
- Rutherford class 1,5 or 6
- more than two stenotic lesions in the target vessel requiring treatment
- inflow lesion (proximal to the study lesion) with flow limitation not being successfully treated prior to the study lesion
- in-stent restenosis of the study lesion
- strongly calcified lesions with circumferential presence of calcifications and a lesion calcification length of >4 cm
- reference vessel diameter <4 mm and >6 mm
Show all 17Show fewer
- guide wire could not be successfully advanced across the lesion
- lesions below the knee requiring treatment
- target lesion is located in the PII-segment of the popliteal artery (A.pop.) or within a bypass graft
- acute thrombosis of the study lesion requiring lysis or thrombectomy prior to the treatment of the study lesion
- potential loss of leg due to critical or acute ischemia
- no patent distal run-off vessel
- medical reason against double anti-platelet therapy in anti-coagulated patient, e.g., receiving coumarine or conditions which prevent the intake of the double anti-platelet therapy for two months
- female patient who is pregnant or lactating
- under 18 years of age
- patients under administrative or judicial custody (§20 Act on medical Devices, Germany)
- expected life span of less than 24 months
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Germany9 sites
Klinikum Arnsberg, Karolinen-Hospital
Arnsberg
Herzzentrum Bad Krozingen
Bad Krozingen
Ihre-Radiologen Standort Franziskus-Krankenhaus
Berlin
Ihre-Radiologen Standort Jüdisches Krankenhaus
Berlin
Vivantes Klinikum Neukölln
Berlin
Diakonissenkrankenhaus Flensburg
Flensburg
SANA Kliniken Lübeck
Lübeck
Universitätklinikum Lübeck
Lübeck
RoMed Klinikum
Rosenheim, Bavaria
About this study
Patients with peripheral artery disease will be treated with either drug coated balloon catheter, drug coated stent or uncoated stent.
Read the detailed description
Patients with chronic stenotic or occlusive atherosclerotic disease and lesions of at least 13 cm length in the SFA or Arteria poplitea segment 1 will be randomized to either treatment with paclitaxel coated balloon catheter, paclitaxel coated stent or bare nitinol stent. Vessel patency will be evaluated by quantitative angiography after 12 months. Clinical follow-ups will be done until 36 months post-intervention.
- Conditions
- Stenosis, Occlusion, Restenosis
- Being tested
- SeQuent Please OTW, Eluvia Vascular Stent System, Nitinol stent
- Keywords
- PAOD, drug coated balloon, drug coated stent, percutaneous transluminal angioplasty (PTA)
- Medical subject headings
- Constriction, Pathologic, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeQuent Please OTWDevice
Dilatation of occluded or highly stenosed vessel with paclitaxel-coated balloon catheter
Eluvia Vascular Stent SystemDevice
Dilatation of occluded or highly stenosed vessel with paclitaxel-coated stent
Nitinol stentDevice
Dilatation of occluded or highly stenosed vessel with uncoated bare nitinol stent
| Study group | Role | What they receive |
|---|---|---|
| Drug coated balloon catheter | Experimental | PTA with paclitaxel coated "SeQuent Please OTW" Receives: Device: SeQuent Please OTW |
| Drug coated stent | Active comparator | PTA with paclitaxel coated "Eluvia Vascular Stent System" Receives: Device: Eluvia Vascular Stent System |
| Uncoated stent | Active comparator | PTA with bare nitinol stent (as commonly used in site) Receives: Device: Nitinol stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent diameter stenosis at 1 year post intervention in successfully treated patients
by quantitative angiography
Measured: 12 +/- 2 months
Secondary outcomes (3)
Late Lumen Loss
by quantitative angiography
Measured: 12 months
Binary restenosis
by DUS
Measured: 6,12, 24, 36 months
Target lesion revascularization
number of re-interventions at target lesion
Measured: 6, 12, 24, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start30 Mar 2017
- Primary completion31 Jan 2022
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Vessel patency will be compared by quantitative angiography at 12 months in patients who have been treated either with paclitaxel coated balloon catheter, paclitaxel coated stent or bare metal stent in femoropopliteal arteries
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- InnoRa GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Scientific Corporation, B. Braun Melsungen AG
- Responsible party
- Sponsor
- Investigators
- Gunnar Tepe, MD, Principal investigator, RoMed Klinikum Rosenheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332264
- Sponsor's protocol ID
- SP01
- Acronym
- SPORTS
- Status last verified
- Feb 2024
- First submitted
- 27 Oct 2017
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequent Please Drug Coated Balloons Versus Primary Stent Application in Long SFA Lesions
- ClinicalTrials.gov ID
- NCT03332264
- Acronym / sponsor ID
- SPORTS / SP01
- Conditions
- Stenosis, Occlusion, Restenosis
- Keywords
- PAOD, drug coated balloon, drug coated stent, percutaneous transluminal angioplasty (PTA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- InnoRa GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Boston Scientific Corporation, B. Braun Melsungen AG
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 6 Nov 2017 (actual)
- 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.
Patients with peripheral artery disease will be treated with either drug coated balloon catheter, drug coated stent or uncoated stent.
Detailed description
Patients with chronic stenotic or occlusive atherosclerotic disease and lesions of at least 13 cm length in the SFA or Arteria poplitea segment 1 will be randomized to either treatment with paclitaxel coated balloon catheter, paclitaxel coated stent or bare nitinol stent. Vessel patency will be evaluated by quantitative angiography after 12 months. Clinical follow-ups will be done until 36 months post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Vessel patency will be compared by quantitative angiography at 12 months in patients who have been treated either with paclitaxel coated balloon catheter, paclitaxel coated stent or bare metal stent in femoropopliteal arteries
| Arm | Type | Receives |
|---|---|---|
| Drug coated balloon catheter | Experimental | Device: SeQuent Please OTWPTA with paclitaxel coated "SeQuent Please OTW" |
| Drug coated stent | Active comparator | Device: Eluvia Vascular Stent SystemPTA with paclitaxel coated "Eluvia Vascular Stent System" |
| Uncoated stent | Active comparator | Device: Nitinol stentPTA with bare nitinol stent (as commonly used in site) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- PAOD and Rutherford classes 2 - 4 (pain-free walking distance <500 m)
- eligible for peripheral revascularization by means of PTA
- peripheral lesions in the superficial femoral artery (SFA) and / or the PI-segment of the popliteal artery (A.pop.)
- minimum diameter stenosis of ≥70%
- treatment length at least 15 cm (lesion length at least 13 cm)
Key exclusion criteria (17 listed)
- Rutherford class 1,5 or 6
- more than two stenotic lesions in the target vessel requiring treatment
- inflow lesion (proximal to the study lesion) with flow limitation not being successfully treated prior to the study lesion
- in-stent restenosis of the study lesion
- strongly calcified lesions with circumferential presence of calcifications and a lesion calcification length of >4 cm
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 |
|---|---|---|
| SeQuent Please OTWDilatation of occluded or highly stenosed vessel with paclitaxel-coated balloon catheter | Device | Drug coated balloon catheter |
| Eluvia Vascular Stent SystemDilatation of occluded or highly stenosed vessel with paclitaxel-coated stent | Device | Drug coated stent |
| Nitinol stentDilatation of occluded or highly stenosed vessel with uncoated bare nitinol stent | Device | Uncoated stent |
Primary outcome
Percent diameter stenosis at 1 year post intervention in successfully treated patients
Time frame: 12 +/- 2 months
by quantitative angiography
3 secondary outcomes
Late Lumen Loss
Time frame: 12 months
Binary restenosis
Time frame: 6,12, 24, 36 months
Target lesion revascularization
Time frame: 6, 12, 24, 36 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 15 Feb 2024.
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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.
Gunnar Tepe, MD principal investigator
RoMed Klinikum Rosenheim
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SeQuent Please OTW, Eluvia Vascular Stent System and Nitinol stent in people with Stenosis and Occlusion, run by InnoRa GmbH at 10 sites in 2 countries.
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 8 inclusion and 17 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 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Austria. 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?
Percent diameter stenosis at 1 year post intervention in successfully treated patients (time frame: 12 +/- 2 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 15 Feb 2024.