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

Spectranetics Corporation49 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Conditions

Peripheral Arterial Disease

Interventions

StellarexTM 0.014" Over-The-Wire Drug-coated Angioplasty BalloonCOMBINATION_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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 6 months

Secondary Outcomes

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

Defined as a composite rate of all-cause death, target limb major amputation and CD-TLR

Time frame: 6 Months

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

Defined as a composite rate of all-cause death, target limb major amputation and CD-TLR

Data from ClinicalTrials.gov

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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

Time frame: 12 months

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

Defined as a composite rate of all-cause death, target limb major amputation and CD-TLR

Time frame: 24 months

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

Rate of CD-TLR

Time frame: 6 months

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

Rate of CD-TLR

Time frame: 12 months

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

Rate of CD-TLR

Time frame: 24 months

Patency rate at 6, 12 and 24 months, defined as the presence of target lesion flow (absence of occlusion or no flow) as determined by Duplex Ultrasound (DUS) and freedom from CD-TLR

Patency rate

Time frame: 6 months

Patency rate at 6, 12 and 24 months, defined as the presence of target lesion flow (absence of occlusion or no flow) as determined by Duplex Ultrasound (DUS) and freedom from CD-TLR

Patency rate

Time frame: 12 months

Patency rate at 6, 12 and 24 months, defined as the presence of target lesion flow (absence of occlusion or no flow) as determined by Duplex Ultrasound (DUS) and freedom from CD-TLR

Patency rate

Time frame: 24 months

Rate of procedural complications defined as occurrence of all-cause death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, or thrombosis of target vessel through the end of the procedure

Rate of procedural complications

Time frame: through study completion, approximately 5 years

Rate of device or procedure related death at 30 days

Rate of device or procedure related death

Time frame: 30 days

Rate of major target limb amputation at 6 months post-procedure

Rate of major target limb amputation

Time frame: 6 months

Rate of major target limb amputation at 12 months post-procedure

Rate of major target limb amputation

Time frame: 12 months

Rate of major target limb amputation at 24 months post-procedure

Rate of major target limb amputation

Time frame: 24 months

Rate of clinically driven target vessel revascularization through 6 months

Rate of clinically driven target vessel revascularization

Time frame: 6 months

Rate of clinically driven target vessel revascularization through 12 months

Rate of clinically driven target vessel revascularization

Time frame: 12 months

Rate of clinically driven target vessel revascularization through 24 months

Rate of clinically driven target vessel revascularization

Time frame: 24 months

Lesion success:

Achievement of a final in-lesion residual diameter stenosis of \<50% (as determined by the angiographic core laboratory), using allowed pretreatment devices after guidewire passage through the lesion

Time frame: Through study completion, approximately 5 years

Technical success:

Achievement of a final in-lesion residual diameter stenosis of \<50% (as determined by the angiographic core laboratory), using the Stellarex 0.014" Drug-Coated Balloon without a device malfunction after a guidewire passage through the l

Time frame: Through study completion, approximately 5 years

Change in waveforms/TcPO2 from pre-procedure to 30 days

Change in waveforms/TcPO2 from pre-procedure

Time frame: 30 days

Change in waveforms/TcPO2 from pre-procedure to 6 months

Change in waveforms/TcPO2 from pre-procedure

Time frame: 6 months

Change in waveforms/TcPO2 from pre-procedure to 12 months

Change in waveforms/TcPO2 from pre-procedure

Time frame: 12 months

Change in waveforms/TcPO2 from pre-procedure to 24 months

Change in waveforms/TcPO2 from pre-procedure

Time frame: 24 months

Change in ankle-brachial index (ABI) from pre-procedure to 30 days

Change in ankle-brachial index (ABI) from pre-procedure

Time frame: 30 days

Change in ankle-brachial index (ABI) from pre-procedure to 6 months

Change in ankle-brachial index (ABI) from pre-procedure

Time frame: 6 months

Change in ankle-brachial index (ABI) from pre-procedure to 12 months

Change in ankle-brachial index (ABI) from pre-procedure

Time frame: 12 months

Change in ankle-brachial index (ABI) from pre-procedure to 24 months

Change in ankle-brachial index (ABI) from pre-procedure

Time frame: 24 months

Change in toe pressures (TP) from pre-procedure to 30 days

Change in toe pressures (TP) from pre-procedure

Time frame: 30 days

Change in toe pressures (TP) from pre-procedure to 6 months

Change in toe pressures (TP) from pre-procedure

Time frame: 6 months

Change in toe pressures (TP) from pre-procedure to 12 months

Change in toe pressures (TP) from pre-procedure

Time frame: 12 months

Change in toe pressures (TP) from pre-procedure to 24 months

Change in toe pressures (TP) from pre-procedure

Time frame: 24 months

Change in Rutherford-Becker Classification (RCC) from pre-procedure to 30 days

Change in Rutherford-Becker Classification (RCC) from pre-procedure

Time frame: 30 days

Change in Rutherford-Becker Classification (RCC) from pre-procedure to 6 months

Change in Rutherford-Becker Classification (RCC) from pre-procedure

Time frame: 6 months

Change in Rutherford-Becker Classification (RCC) from pre-procedure to 12 months

Change in Rutherford-Becker Classification (RCC) from pre-procedure

Time frame: 12 months

Change in Rutherford-Becker Classification (RCC) from pre-procedure to 24 months

Change in Rutherford-Becker Classification (RCC) from pre-procedure

Time frame: 24 months

Change in EQ-5D from pre-procedure to 30 days

Change in EQ-5D-5L (EuroQual-5 Dimension scale set and Visual Analog Scale score) from pre-procedure. Dimension score reporting will be determined at time of reporting and VAS score will be reported based on subject indicated scale from 0 to 100, where higher scores indicate positive outcome improvement.

Time frame: 30 days

Change in EQ-5D from pre-procedure to 6 months

Time frame: 6 months

Change in EQ-5D from pre-procedure to 12 months

Time frame: 12 months

Change in EQ-5D from pre-procedure to 24 months

Time frame: 24 months

In RCC 5 subjects, percentage of wounds healed from baseline to 30 days post-procedure as reported by the Investigator at the Investigative site

In RCC 5 subjects, percentage of wounds healed from baseline

Time frame: 30 days

In RCC 5 subjects, percentage of wounds healed from baseline to 6 months post-procedure as reported by the Investigator at the Investigative site

In RCC 5 subjects, percentage of wounds healed from baseline

Time frame: 6 months

In RCC 5 subjects, percentage of wounds healed from baseline to 12 months post-procedure as reported by the Investigator at the Investigative site

In RCC 5 subjects, percentage of wounds healed from baseline

Time frame: 12 months