The ILLUMINA Study. (ILLUMINA)

NCT03510676 | Completed DMC

• 1 other identifier: P41302
• Study Type: interventional
• Target: 100
• Locations: 3 countries
• Sites: 10

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  12 months after procedure

Study Arms (1)

NiTiDES

EXPERIMENTAL

Single arm

Device: NiTiDES

Interventions

NiTiDES DEVICE

NiTiDES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• CID - Carbostent & Implantable Devices: lead

Study Sites (10)

Polyclinique Les Fleurs

Ollioules, 83190, France

Location

Centre Privé Claude Galien

Quincy-sous-Sénart, 91480, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Universitäts-Herzzentrum Freiburg

Bad Krozingen, 79189, Germany

Location

St. Gertrauden Krankenhaus GmbH

Berlin, 10713, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Regiomed GefäBzentrum Sonneberg

Sonneberg, 96515, Germany

Location

Maria Cecilia Hospital

Cotignola, Ravenna, 48033, Italy

Location

San Raffaele Hospital

Milan, 20132, Italy

Location

IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location

Related Publications (1)

• 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.

  PMID: 35219622 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Dierk Scheinert

  Universitätsklinikum Leipzig, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 27, 2018
• Study Start: January 26, 2016
• Primary Completion: March 7, 2018
• Study Completion: March 7, 2019
• Last Updated: July 13, 2021

Record last verified: 2021-07

Locations

IT (3); DE (4); FR (3)