ILLUMENATE Below-The-Knee (BTK) Arteries: a Post Market Clinical Study

NCT03395236 | Completed Phase 4 FDA Drug FDA Device

• 1 other identifier: D037012
• Study Type: interventional
• Target: 49
• Locations: 3 countries
• Sites: 10

Brief Summary

The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the StellarexTM 0.014" OTW Drug-coated Angioplasty Balloon in the treatment of lesions in "below the knee" popliteal (P3 segment) and infra-popliteal arteries according to the Instructions for Use in Rutherford-Becker Classification (RCC) 3, 4 and 5 patient populations. This study will be conducted in Europe across up to 10 centers in up to 75 subjects. Office visits will occur at 30 days, 6, 12, and 24 months post-index procedure.

Conditions

Peripheral Arterial Disease

Keywords

Critical Limb Ischemia; CLI; Claudication; PAD; BTK; Below The Knee

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint-Composite Major Adverse Limb Events (MALE) + perioperative death (POD); the composite is the number of participants who do not have MALE or POD at 30 days

  Major Adverse Limb Event (MALE) is defined as the composite of either major amputation or major re-intervention through 30 days of the index procedure. Major re-intervention is defined as creation of a new surgical bypass graft, the use of thrombectomy or thrombolysis or a major surgical graft revision such as a jump graft or an interposition graft. This is a single endpoint as it is a composite only subjects who do not have MALE or POD will be counted toward this endpoint MALE is defined as the composite of either major amputation or major re-intervention through 30 days of the index procedure. Major re-intervention is defined as creation of a new surgical bypass graft, the use of thrombectomy or thrombolysis or a major surgical graft revision such as a jump graft or an interposition graft. POD is all-cause death through 30 days of the index procedure.

  30 days

• Primary Performance Endpoint-Composite patency + limb salvage through 6 months; the composite is the number of participants with patency and limb salvage at 6 months

  Patency defined as freedom from occluded target lesions (flow/no flow) verified by duplex ultrasound and clinically-driven target lesion revascularization (CD-TLR) Freedom from major amputation in the Target Limb This is a single endpoint as only subjects with both patency and limb salvage will be considered for this endpoint.

  6 months

Secondary Outcomes (42)

• Major adverse event (MAE) rate at 6,12, and 24 months post index procedure

  6 Months

• Major adverse event (MAE) rate at 6,12, and 24 months post index procedure

  12 months

• Major adverse event (MAE) rate at 6,12, and 24 months post index procedure

  24 months

• Rate of CD-TLR at 6, 12 and 24 months

  6 months

• Rate of CD-TLR at 6, 12 and 24 months

  12 months

Study Arms (1)

Treatment

EXPERIMENTAL

StellarexTM 0.014 OTW Drug-coated Angioplasty Balloon (Stellarex Balloon)

Combination Product: StellarexTM 0.014" Over-The-Wire Drug-coated Angioplasty Balloon

Interventions

StellarexTM 0.014" Over-The-Wire Drug-coated Angioplasty Balloon COMBINATION_PRODUCT

The Stellarex balloon (0.014") is indicated for the treatment of de-novo or re-stenotic lesions in the lower extremities to establish blood flow and to maintain vessel patency.

Treatment

Eligibility Criteria

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

You may qualify if:

• Subjects intended to be treated with the Stellarex 0.014" Drug-Coated Balloon for de-novo or restenotic lesions in native "below the knee" popliteal (P3 segment) and infra-popliteal arteries ending at the tibiotalar joint (ankle), as per the Instruction for Use (IFU).
• Rutherford-Becker clinical category classification (RCC) 3 patients with claudication or RCC 4 or 5 subjects with documented Critical Limb Ischemia (CLI) defined as 2.1 RCC 3 subjects: subjects with severe claudication 2.2 RCC 4 subjects: subjects with persistent, recurring ischemic rest pain requiring analgesia for at least two weeks or 2.3 RCC 5 subjects: subjects with minor tissue loss of the foot or toes or
• Age ≥18 years old.
• Reconstitution of the target vessel at the ankle and run-off into a patent dorsalis pedis or plantar arteries defined as \<50% stenosis by visual estimate.
• Is able and willing to provide written informed consent and comply with all required follow-up evaluations within the defined follow-up visit windows prior to enrollment in the study.
• Life expectancy \> 1 year.

You may not qualify if:

• Subjects with any medical condition that would make him/her inappropriate for treatment with the Stellarex balloon as per the Instructions for Use (IFU) or in the opinion of the investigator.
• Has impaired renal function defined as serum creatinine \>2.5 mg/dl that cannot be adequately pre-treated or subjects on dialysis.
• Subjects already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
• Subjects that in the judgment of the investigator would require treatment of the contralateral limb within 3 days prior to the index procedure or 30 days after. Note: Unless contralateral treatment is required to facilitate adequate access to the target lesion (e.g. contralateral iliac).
• Previous or planned surgical or catheter-based procedure within 3 days before or 30 days after the index procedure. Note: This excludes successful inflow artery treatment within the same hospitalization or a documented preplanned minor amputation.
• Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤ 30% without major vascular complication (e.g. absence of flow-limiting dissection, embolic event). These inflow arteries must be treated without the need for laser, atherectomy, thrombectomy, cryoplasty, brachytherapy and cutting/scoring balloons. Treatment with a Stellarex DCB of the inflow lesion, if according to its intended use, is allowed.
• Prior endovascular treatment of the target lesion within three (3) months of the index procedure.
• Prior stent placement in the target lesion(s).
• Single focal lesion \< 4cm in length in the absence of additional treatable popliteal or infra-popliteal lesions.
• Subjects confined to bed that are completely non-ambulatory.
• For RCC 5 subjects: Non-arterial ulcers such as venous ulcers, neurotrophic ulcers, heel pressure ulcers, ulcers potentially involving calcaneus region or ulcers in the proximal one-half of the foot or higher (from mid-foot and higher going up the leg).
• Subjects scheduled to undergo a planned major amputation.
• Presence of concentric calcification that precludes adequate vessel preparation per IFU.

Sponsors & Collaborators

• Spectranetics Corporation: lead

Study Sites (10)

Cardiologisches Centrum Bethanien

Frankfurt, Germany

Location

Asklepios Kliniken Hamburg GmbH

Hamburg, Germany

Location

Klinik Immenstadt, Herz und GefaSzentrum Immenstadt

Immenstadt im Allgäu, Germany

Location

Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

Mainz, Germany

Location

RoMed Klinikum Rosenheim

Rosenheim, Germany

Location

Albert Schweitzer Hospital

Dordrecht, Netherlands

Location

St. Antonius Hospital

Nieuwegein, Netherlands

Location

Cambridge University Hospital

Cambridge, United Kingdom

Location

Guys and St. Thomas Hospital

London, United Kingdom

Location

The Royal Free Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Signs and Symptoms

Study Officials

• Gunnar Tepe, MD

  Institut für Diagnostische und Interventionelle Radiologie, RoMed Klinikum Rosenheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: January 10, 2018
• Study Start: April 20, 2018
• Primary Completion: August 23, 2023
• Study Completion: August 23, 2023
• Last Updated: January 24, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5); NL (2); GB (3)