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

NCT ID: NCT03395236

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-20
• Study Completion Date: 2023-08-23

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.

Detailed Description

There is a significant amount of evidence that the use of Paclitaxel-coated balloons in the treatment of peripheral arterial disease (PAD) has demonstrated favorable outcomes when used to treat lesions in the superficial femoral and popliteal arteries. For subjects with lesions in the infrapopliteal arteries, which includes lesions in the mid to distal popliteal artery and below, a smaller profile balloon is necessary. Typically, lesions in the SFA and proximal popliteal arteries are treated by larger diameter balloons and larger sized guidewires (most commonly 0.018" or 0.035") which are too large for vessels below-the-knee. For this reason, the Stellarex™ 0.014" OTW Drug-coated Angioplasty Balloon was developed as a line extension to the Stellarex™ 0.035" device in order to accommodate the treatment of these smaller vessels. The Stellarex™ 0.014" balloon has the same drug concentration and is manufactured using a similar method as the Stellarex™ 0.035" device. Additionally, the Stellarex™ 0.035" and 0.014" balloon share a common balloon diameter of 4 mm, a size which was used to treat lesions throughout the popliteal artery in the previous Stellarex 0.035" studies. For the reasons noted above, equivalence between the two devices has been demonstrated. Furthermore, it is believed that the 0.014" device will not demonstrate any performance differences nor change the anticipated or residual risks.

In conclusion, the current study has been developed in agreement with post-market requirements as per the Post Market Clinical Follow up (PMCF) plan. The prospective design of the study, the sample size and the selected outcomes will be able to provide the additional clinical information to support the safe use and performance of the Stellarex 0.014" device in the intended population of patients with below-the-knee arterial disease.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. 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).

2. 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

3. Age ≥18 years old.

4. 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.

5. 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.

6. Life expectancy > 1 year.

Exclusion Criteria

1. 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.

2. Has impaired renal function defined as serum creatinine >2.5 mg/dl that cannot be adequately pre-treated or subjects on dialysis.

3. Subjects already enrolled in other investigational (interventional) studies that would interfere with study endpoints.

4. 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).

5. 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.

6. Prior endovascular treatment of the target lesion within three (3) months of the index procedure.

7. Prior stent placement in the target lesion(s).

8. Single focal lesion < 4cm in length in the absence of additional treatable popliteal or infra-popliteal lesions.

9. Subjects confined to bed that are completely non-ambulatory.

10. 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).

11. Subjects scheduled to undergo a planned major amputation.

12. Presence of concentric calcification that precludes adequate vessel preparation per IFU.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spectranetics Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gunnar Tepe, MD

Role: PRINCIPAL_INVESTIGATOR

Institut für Diagnostische und Interventionelle Radiologie, RoMed Klinikum Rosenheim

Locations

Cardiologisches Centrum Bethanien

Frankfurt, , Germany

Asklepios Kliniken Hamburg GmbH

Hamburg, , Germany

Klinik Immenstadt, Herz und GefaSzentrum Immenstadt

Immenstadt im Allgäu, , Germany

Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

Mainz, , Germany

RoMed Klinikum Rosenheim

Rosenheim, , Germany

Albert Schweitzer Hospital

Dordrecht, , Netherlands

St. Antonius Hospital

Nieuwegein, , Netherlands

Cambridge University Hospital

Cambridge, , United Kingdom

Guys and St. Thomas Hospital

London, , United Kingdom

The Royal Free Hospital

London, , United Kingdom

Countries

Germany; Netherlands; United Kingdom

Other Identifiers

D037012

Identifier Type: -

Identifier Source: org_study_id