The ILLUMINA Study. (ILLUMINA) (ILLUMINA)

• ClinicalTrials.gov Identifier: NCT03510676
• Recruitment Status: Completed
• First Posted: April 27, 2018
• Last Update Posted: July 13, 2021
• Sponsor: CID - Carbostent & Implantable Devices
• Information provided by (Responsible Party): CID - Carbostent & Implantable Devices

Study Description

Brief 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 femoral arteries or/and proximal popliteal arteries.

Condition or disease	Intervention/treatment	Phase
Peripheral Arterial Disease	Device: NiTiDES	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Innovative siroLimus seLf Expanding drUg-eluting Stent for the treatMent of perIpheral Disease: Evaluation of Safety aNd efficAcy. The ILLUMINA Study. (ILLUMINA)
• Actual Study Start Date: January 26, 2016
• Actual Primary Completion Date: March 7, 2018
• Actual Study Completion Date: March 7, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: NiTiDES; Single arm	Device: NiTiDES

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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.

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.

Exclusion Criteria:

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;
• 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).

Contacts and Locations

Locations

France

Polyclinique Les Fleurs

Ollioules, France, 83190

Centre Privé Claude Galien

Quincy sous Sénart, France, 91480

Clinique Pasteur

Toulouse, France, 31076

Germany

Universitäts-Herzzentrum Freiburg

Bad Krozingen, Germany, 79189

St. Gertrauden Krankenhaus GmbH

Berlin, Germany, 10713

Universitätsklinikum Leipzig

Leipzig, Germany, 04103

Regiomed GefäBzentrum Sonneberg

Sonneberg, Germany, 96515

Italy

Maria Cecilia Hospital

Cotignola, Ravenna, Italy, 48033

San Raffaele Hospital

Milan, Italy, 20132

IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Sponsors and Collaborators

CID - Carbostent & Implantable Devices

Investigators

• Principal Investigator: Dierk Scheinert; Universitätsklinikum Leipzig, Germany

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: CID - Carbostent & Implantable Devices
• ClinicalTrials.gov Identifier: NCT03510676
• Other Study ID Numbers: P41302
• First Posted: April 27, 2018
• Last Update Posted: July 13, 2021
• Last Verified: July 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases