Peripheral Arterial DiseaseILLUMINANCT03510676
The ILLUMINA Study. (ILLUMINA)
A study testing NiTiDES in people with Peripheral Arterial Disease, run by CID - Carbostent & Implantable Devices at 10 sites in 3 countries.
Trial summary
The aim of the prospective, multicentre, single-arm study is to assess safety and efficacy of a drug eluting stent in Nitinol alloy (NiTiDES) in term of vessel patency and composite event-free survival rate up to two years follow-up in focal/medium length lesions in patients with ischemic obstruction of superficial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- NiTiDES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 26 Jan 2016to 7 Mar 2019
- 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
- Clinical
- Patient must be over 18 years inclusive at the time of consent prior to participation in the study and must understand the purpose of this study and be willing to adhere to the study procedures described in this protocol;
- A female of childbearing potential may be enrolled, provided she has a negative pregnancy test at screening;
- Patient has signed and dated the informed consent;
- Patient has symptoms of peripheral arterial disease classified as Rutherford Category (2-4); patients with Rutherford Category 2 can be included only if a conservative and/or medication therapy was unsuccessful.
- Patient has a resting ABI <0.9 or at exercise if resting ABI is normal; patient with incompressible arteries (ABI >1.2) at rest or at exercise must have a toe-brachial index (TBI) <0.8.
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- Angiographic
- Patient has one documented stenotic or occluded atherosclerotic lesion (lesion length ≤ 14 cm) of the above-the-knee femoropopliteal artery, in one limb, that meet all of the inclusion criteria and none of the exclusion criteria;
- Patient has a de novo or restenotic lesion with >50% stenosis documented angiographically and no prior stent in the target lesion;
- The target lesion must be appropriately covered (margin of 5.0 mm on both sides of the stent) by one or two study stents (NiTiDES). Any occurred dissection of the target vessel must be treated with an additional stent (NiTiDES);
- Tandem lesions are allowed if the distance between 2 lesions is ≤ 3 cm and the total length of all lesions ≤ 14 cm;
- Guidewire successfully passed the lesion through the lumen.
Who cannot join
- Clinical
- Patient is pregnant or breast-feeding;
- Patient is simultaneously participating in another investigational drug or device study;
- Patient has any planned surgical or interventional procedure within 30 days after the study procedure;
- Clinical conditions, disorders or allergies that limit the use of anti-platelet and/or anticoagulant therapy;
- Severe allergy to the contrast medium or drugs used during the procedure;
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- Patients with known hypersensitivity or allergies to Sirolimus, fatty acids (such as stearic acid, palmitic acid, behenic acid) or the metal components of the stent (such as Nickel, Titanium and Tantalum);
- Serum creatinine > 2.5 mg/dl;
- Myocardial infarction within the 90 days prior to enrollment;
- Hypercoagulable state;
- Uncontrollable hypertension;
- Life expectancy < 12 months;
- Aneurysmal disease of abdominal aorta, iliac artery and popliteal artery;
- Gastrointestinal bleeding;
- Stroke within the 180 days prior to enrollment;
- Concomitant therapies such as: atherectomy, cryoplasty, scoring / cutting balloons.
- Angiographic
- Patient has significant stenosis or occlusion of inflow tract not successfully treated before this procedure;
- Patient has had previous stenting of target vessel;
- Patient lacks at least one patent vessel of runoff with <50% stenosis throughout its course;
- Patient has untreated angiographically-evident thrombus in the target lesion;
- Patients intended to be treated with more than two stents in the target lesion unless additional stent required in case of dissection;
- Patient intended to receive different stent from NiTiDES in target lesion;
- Technically unsuccessful Percutaneous Transluminal Angioplasty (PTA) procedure, for example due to the impossibility of accessing the stenotic site with a delivery system
- Lesions considered untreatable with PTA or other interventional techniques;
- Inflow lesion ≥15 cm long or occlusion (any length) in the ipsilateral Iliac artery;
- Not successfully treated < 15 cm long inflow lesion in the ipsilateral iliac artery [Treatment of inflow lesion must precede patient enrollment and target lesion treatment. No Drug Eluting Stents (DES) and / or Drug Eluting Balloon (DEB) allowed for the treatment of inflow lesions];
- Lesions in contralateral Superficial Femoral Artery (SFA) that require intervention during the index procedure, or within 30 days after the index procedure. Lesions in contralateral SFA can be treated either >30 days prior to or > 30 days after the index procedure;
- Patient with stenosis adjacent to an aneurysmal lesion of diameter at least twice the lumen of the native vessel;
- Lesions localized in the two distal thirds of the popliteal artery (or at the knee joint, generally considered).
- Others.
- Patients under judicial protection, tutorship or curatorship (for France only).
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Germany4 sites
Universitäts-Herzzentrum Freiburg
Bad Krozingen, 79189
St. Gertrauden Krankenhaus GmbH
Berlin, 10713
Universitätsklinikum Leipzig
Leipzig, 04103
Regiomed GefäBzentrum Sonneberg
Sonneberg, 96515
France3 sites
Polyclinique Les Fleurs
Ollioules, 83190
Centre Privé Claude Galien
Quincy-sous-Sénart, 91480
Clinique Pasteur
Toulouse, 31076
Italy3 sites
Maria Cecilia Hospital
Cotignola, Ravenna, 48033
San Raffaele Hospital
Milan, 20132
IRCCS Policlinico San Matteo
Pavia, 27100
About this study
Official title: Innovative siroLimus seLf Expanding drUg-eluting Stent for the treatMent of perIpheral Disease: Evaluation of Safety aNd efficAcy. The ILLUMINA Study. (ILLUMINA)
The aim of the prospective, multicentre, single-arm study is to assess safety and efficacy of a drug eluting stent in Nitinol alloy (NiTiDES) in term of vessel patency and composite event-free survival rate up to two years follow-up in focal/medium length lesions in patients with ischemic obstruction of superficial femoral arteries or/and proximal popliteal arteries.
- Conditions
- Peripheral Arterial Disease
- Being tested
- NiTiDES
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiTiDESDevice
| Study group | Role | What they receive |
|---|---|---|
| NiTiDES | Experimental | Single arm Receives: Device: NiTiDES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival rate from Major Adverse Events
Freedom from Clinical Events Committee (CEC) adjudicated Major Adverse Event (death, target limb amputation, target limb ischemia requiring surgical intervention or surgical repair of target vessel or clinically-driven target lesion revascularization) or worsening of the Rutherford score by 2 classes, or to class 5 or 6.
Measured: 12 months after procedure
Primary patency (absence of clinically-driven target lesion revascularization or binary restenosis)
Primary patency is defined as absence of clinically-driven target lesion revascularization or binary restenosis; binary restenosis is defined as a peak systolic velocity ratio (PSVR) >2.4 (duplex evaluation)
Measured: 12 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start26 Jan 2016
- Primary completion7 Mar 2018
- Study completion7 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- CID - Carbostent & Implantable Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dierk Scheinert, Principal investigator, Universitätsklinikum Leipzig, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510676
- Sponsor's protocol ID
- P41302
- Acronym
- ILLUMINA
- Status last verified
- Jul 2021
- First submitted
- 4 Apr 2018
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Steiner S, Honton B, Langhoff R, Chiesa R, Kahlberg A, Thieme M, Zeller T, Garot P, Commeau P, Cremonesi A, Marone EM, Sauguet A, Scheinert D. 2-Year Results With a Sirolimus-Eluting Self-Expanding Stent for Femoropopliteal Lesions: The First-in-Human ILLUMINA Study. JACC Cardiovasc Interv. 2022 Mar 28;15(6):618-626. doi: 10.1016/j.jcin.2021.12.034. Epub 2022 Feb 23.
PubMed 35219622
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative siroLimus seLf Expanding drUg-eluting Stent for the treatMent of perIpheral Disease: Evaluation of Safety aNd efficAcy. The ILLUMINA Study. (ILLUMINA)
- ClinicalTrials.gov ID
- NCT03510676
- Acronym / sponsor ID
- ILLUMINA / P41302
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- CID - Carbostent & Implantable DevicesIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2016 (actual)
- Primary completion
- 7 Mar 2018 (actual)
- Study completion
- 7 Mar 2019 (actual)
- First posted
- 27 Apr 2018 (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.
The aim of the prospective, multicentre, single-arm study is to assess safety and efficacy of a drug eluting stent in Nitinol alloy (NiTiDES) in term of vessel patency and composite event-free survival rate up to two years follow-up in focal/medium length lesions in patients with ischemic obstruction of superficial femoral arteries or/and proximal popliteal arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NiTiDES | Experimental | Device: NiTiDESSingle arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Clinical
- Patient must be over 18 years inclusive at the time of consent prior to participation in the study and must understand the purpose of this study and be willing to adhere to the study procedures described in this protocol;
- A female of childbearing potential may be enrolled, provided she has a negative pregnancy test at screening;
- Patient has signed and dated the informed consent;
- Patient has symptoms of peripheral arterial disease classified as Rutherford Category (2-4); patients with Rutherford Category 2 can be included only if a conservative and/or medication therapy was unsuccessful.
Key exclusion criteria (32 listed)
- Clinical
- Patient is pregnant or breast-feeding;
- Patient is simultaneously participating in another investigational drug or device study;
- Patient has any planned surgical or interventional procedure within 30 days after the study procedure;
- Clinical conditions, disorders or allergies that limit the use of anti-platelet and/or anticoagulant therapy;
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 |
|---|---|---|
| NiTiDES | Device | NiTiDES |
Primary outcome
Event-free survival rate from Major Adverse Events
Time frame: 12 months after procedure
Freedom from Clinical Events Committee (CEC) adjudicated Major Adverse Event (death, target limb amputation, target limb ischemia requiring surgical intervention or surgical repair of target vessel or clinically-driven target lesion revascularization) or worsening of the Rutherford score by 2 classes, or to class 5 or 6.
Primary patency (absence of clinically-driven target lesion revascularization or binary restenosis)
Time frame: 12 months after procedure
Primary patency is defined as absence of clinically-driven target lesion revascularization or binary restenosis; binary restenosis is defined as a peak systolic velocity ratio (PSVR) >2.4 (duplex evaluation)
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 13 Jul 2021.
- Derived from this study: PubMed 35219622Steiner S, Honton B, Langhoff R, Chiesa R, Kahlberg A, Thieme M, Zeller T, Garot P, Commeau P, Cremonesi A, Marone EM, Sauguet A, Scheinert D. 2-Year Results With a Sirolimus-Eluting Self-Expanding Stent for Femoropopliteal Lesions: The First-in-Human ILLUMINA Study. JACC Cardiovasc Interv. 2022 Mar 28;15(6):618-626. doi: 10.1016/j.jcin.2021.12.034. Epub 2022 Feb 23.
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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.
Dierk Scheinert principal investigator
Universitätsklinikum Leipzig, Germany
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NiTiDES in people with Peripheral Arterial Disease, run by CID - Carbostent & Implantable Devices at 10 sites in 3 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 12 inclusion and 32 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 13 Jul 2021. 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, France, Italy. 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?
Event-free survival rate from Major Adverse Events (time frame: 12 months after procedure). The study lists 2 primary outcomes in all. 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 NCT03510676, 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 13 Jul 2021.