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Patients With Peripheral Artery Disease in the SFA or PAPhase 1NCT02941224

First-in-human Evaluation of the SELUTION DCB, a Novel Sirolimus Coated Balloon in Peripheral Arteries

A Phase 1 study testing SELUTION DCB (sirolimus coated balloon) in people with Patients With Peripheral Artery Disease in the SFA or PA, run by M.A. Med Alliance S.A. at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the Clinical Investigation is to assess the clinical safety and the inhibition of restenosis of the Investigational Device in the treatment of de-novo occluded/stenotic or re-occluded/restenotic lesions of the superficial femoral and/or popliteal arteries. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SELUTION DCB (sirolimus coated balloon)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
4 sitesGermany
Study dates
Oct 2016to Sep 2019
Phase
Phase 1
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

  • Patients who are mentally and linguistically able to understand the aim of the Clinical Investigation and to show sufficient compliance in following the Clinical Investigation Plan.
  • Patients must agree to return for all required post-index procedure follow-up visits.
  • Patients are able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of the Clinical Investigation. Patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document.
  • Patients have a documented diagnosis of Peripheral Arterial Disease (PAD) classified as Rutherford class 2-3-4 in the Superficial Femoral Artery (SFA) and/or Popliteal Artery (PA). Patients with a documented diagnosis of PAD classified as Rutherford class 2, may only be included in case conservative and medicinal treatment have proved ineffective in these patients.
  • Patients are able to walk without assistive devices such as walker or cane.
  • Patients are eligible for peripheral revascularization by means of PTA.
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  • The target vessel reference diameter must be ≥ 3.0 and ≤ 7.0 mm.
  • The target lesion length must be ≤ 15 cm and stenosed or occluded.
  • The target lesion must be in a native, non-stented SFA and/or PA target vessel and located ≥ 1 cm below the Common Femoral Artery (CFA) bifurcation and terminate distally ≥ 1 cm above the origin of the Tibial-Peroneal (TP) trunk.
  • Treatment of multiple target lesions is allowed, as long as the composite target lesion length is ≤ 15 cm and the target lesions can be treated with a maximum of 2 overlapping Investigational Devices.
  • The target lesion must either be de-novo or restenotic (stenosis ≥ 70% diameter reduction or occlusion by visual estimate). If the target lesion is restenotic, the prior PTA must have been done > 30 days prior-index procedure.
  • The target lesion must have been successfully crossed with a guide wire and there must be successful pre-dilatation of the target lesion, in the absence of early recoil, significant remaining stenosis or flow-limiting dissection.
  • There must be a patent (< 50% stenosis) inflow artery, as confirmed by angiography. Treatment of inflow disease during the index procedure is allowed. Patients with flow-limiting inflow lesions can be included, if inflow lesions have been treated (use of DES or DCB not allowed) successfully (attainment of residual diameter stenosis ≤ 30% without major vascular complications).
  • There must be at least 1 patent (< 50% stenosis) native outflow artery to the ankle, as confirmed by angiography. Treatment of outflow disease during the index procedure is NOT permitted.

Who cannot join

  • Patients with a known hypersensitivity or contraindication to aspirin, heparin, other anticoagulant/anti-platelet therapies, Sirolimus (or analogs) or sensitivity to contrast media that cannot be adequately pre-medicated.
  • Patients with an obligatory need of cumarine or other anticoagulants (e.g. Novel Oral Anticoagulant (NOAC) drugs).
  • Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the Investigational Device.
  • Patients with a life expectancy, from the Investigator's opinion, of less than 3 years.
  • Patients that are currently participating in other clinical investigations involving any investigational drug or device that may potentially confound the results of the Clinical Investigation, or that would limit the patient's compliance with the follow-up requirements of the Clinical Investigation.
  • Patients with a history of Myocardial Infarction (MI), thrombolysis or angina within 30 days prior-index procedure.
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  • Patients with a history of major disabling stroke within 3 months prior-index procedure.
  • Patients with any type of previous or planned surgical or interventional procedure within 15 days prior- and/or within 30 days post-index procedure.
  • Patients with a presence or history of severe renal failure (Glomerular Filtration Rate (GFR) ≤ 30 ml/min).
  • Patients who have undergone prior vascular surgery of the SFA and/or PA in the index limb to treat atherosclerotic disease.
  • Patients with clinically significant aneurysmal disease of the iliac, femoral or popliteal artery and patients with a history of clinically significant abdominal aortic aneurysm.
  • Treatment of the contralateral limb during the same index procedure or within 30 days post-index procedure in order to avoid confounding complications.
  • Patients under administrative or judicial custody (§20 Act on Medical Devices, Germany).
  • Composite target lesion length is > 15 cm.
  • Treatment of target lesion(s) that requires more than 2 overlapping Investigational Devices.
  • A COMPLIANCE360-Score of 3 or higher, showing a (moderately) severe circumferentially calcified target lesion as displayed on plain x-ray prior to the index procedure expected for early recoil and imperative need of plaque modulation or stenting as judged by the investigator prior to pre-dilatation.
  • Significant inflow disease or treatment of inflow disease during index procedure not successful.
  • Known inadequate distal outflow (> 50 % stenosis of distal popliteal and/or all three tibial vessels), or planned treatment of vascular disease distal to the target lesion post-index procedure.
  • Known required use of adjunctive treatment modalities (laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.).
  • Remaining acute or sub-acute thrombus in the target vessel.

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Universitäts-Herzzentrum Freiburg-Bad Krozingen

    Bad Krozingen, Baden-Wurttemberg, 79189

  • Radiologische Gemeinschaftspraxis Ihre-Radiologen Franziskus - Krankenhaus Berlin

    Berlin, 10787

  • Vivantes Klinikum Neukölln

    Berlin, 12351

  • Evangelisches Krankenhaus Hubertus

    Berlin, 14129

Other trials in Germany

About this study

Official title: SELUTION™ Sirolimus Coated PTA Balloon Catheter Prospective, Controlled, Multi-Center, Open, Single-Arm Clinical Investigation for the Treatment of Patients With Femoropopliteal Artery Lesions With a Novel Drug Coated Balloon

The primary objective of the Clinical Investigation is to assess the clinical safety and the inhibition of restenosis of the Investigational Device in the treatment of de-novo occluded/stenotic or re-occluded/restenotic lesions of the superficial femoral and/or popliteal arteries.

The primary endpoint of the Clinical Investigation is Late Lumen Loss (LLL) of the target lesion, as measured by Quantitative Vascular Angiography (QVA) at 6 months post-index procedure.

Being tested
SELUTION DCB (sirolimus coated balloon)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SELUTION DCB (sirolimus coated balloon)Device

Study groups in NCT02941224
Study groupRoleWhat they receive
SELUTION DCBExperimentalThe SELUTION™ DCB (coated with sirolimus) is intended for use as a Percutaneous Transluminal Angioplasty (PTA) balloon catheter to dilate de-novo or restenotic vascular lesions, for the purpose of improving limb perfusion and decreasing the incidence of restenosis.
Receives: Device: SELUTION DCB (sirolimus coated balloon)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Late Lumen Loss (LLL) of the target lesion, as measured by Quantitative Vascular Angiography (QVA)

    Measured: 6 Months (plus or minus 30 days)

Secondary outcomes (13)

  1. Device success

    defined as successful delivery, inflation, deflation and retrieval of the Investigational Device

    Measured: index procedure

  2. Procedural success

    defined as final residual stenosis of ≤ 30% of the target lesion, as measured by QVA

    Measured: index procedure

  3. Clinical success

    defined as procedural success with no MAE noted

    Measured: within 24 hours post-index procedure

  4. Freedom from device- and procedure- related death

    Measured: 30 days

  5. Freedom from Major Adverse Event (MAE)

    defined as composite rate of Cardio-Vascular (CV) mortality, index limb amputation, target lesion thrombosis and clinically driven Target Lesion Revascularization (TLR)

    Measured: 6 Months (plus or minus 30 days)

  6. Primary Patency (PP)

    defined as freedom from clinically driven Target Lesion Revascularization (TLR) and freedom from restenosis as determined by Duplex Ultrasound (DUS) with a Peak Systolic Velocity Ratio (PSVR) < 2.5 of the target lesion

    Measured: discharge, 6, 12 and 24 Months (plus or minus 30 days)

  7. Composite of freedom from index limb amputation and clinically driven Target Vessel Revascularization (TVR)

    Measured: 12 and 24 Months (plus or minus 30 days)

  8. Angiographic Binary Restenosis (ABR)

    defined as > 50% diameter stenosis of the target lesion, as measured by QVA

    Measured: 6 Month (plus or minus 30 days)

  9. Change of Rutherford Classification as compared to baseline

    Measured: at 6, 12 and 24 months (plus or minus 30 days)

  10. Change of Ankle Brachial Index (ABI) as compared to baseline

    Measured: at 6, 12 and 24 months (plus or minus 30 days)

  11. Change in functional status measured by changes in the Walking Impairment compared to baseline

    Measured: at 6, 12 and 24 months (plus or minus 30 days)

  12. Change in functional status measured by changes in the general health-related Quality of Life measured by changes in EQ-5D-5L questionnaire compared to baseline

    Measured: at 6, 12 and 24 months (plus or minus 30 days)

  13. User Acceptance Testing (UAT) questionnaire

    Measured: index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionDec 2017
  4. Study completionSep 2019

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02941224
Sponsor's protocol ID
SP-1001
Status last verified
Nov 2019
First submitted
18 Oct 2016
Last updated
20 Nov 2019
Results posted
No

Publications

  • Zeller T, Brechtel K, Meyer DR, Noory E, Beschorner U, Albrecht T. Six-Month Outcomes From the First-in-Human, Single-Arm SELUTION Sustained-Limus-Release Drug-Eluting Balloon Trial in Femoropopliteal Lesions. J Endovasc Ther. 2020 Oct;27(5):683-690. doi: 10.1177/1526602820941811. Epub 2020 Jul 15.

    PubMed 32666871

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SELUTION DCB (sirolimus coated balloon) in people with Patients With Peripheral Artery Disease in the SFA or PA, run by M.A. Med Alliance S.A. at 4 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 20 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 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 (LLL) of the target lesion, as measured by Quantitative Vascular Angiography (QVA) (time frame: 6 Months (plus or minus 30 days)). 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 NCT02941224, which also lists 1 linked publication.

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 20 Nov 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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