Peripheral Arterial DiseasePhase 4BTK PMSNCT03395236
ILLUMENATE Below-The-Knee (BTK) Arteries: a Post Market Clinical Study
A Phase 4 study testing StellarexTM 0.014" Over-The-Wire Drug-coated Angioplasty Balloon in people with Peripheral Arterial Disease, run by Spectranetics Corporation at 10 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- StellarexTM 0.014" Over-The-Wire Drug-coated Angioplasty Balloon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 20 Apr 2018to 23 Aug 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Germany5 sites
Cardiologisches Centrum Bethanien
Frankfurt
Asklepios Kliniken Hamburg GmbH
Hamburg
Klinik Immenstadt, Herz und GefaSzentrum Immenstadt
Immenstadt im Allgäu
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz
RoMed Klinikum Rosenheim
Rosenheim
United Kingdom3 sites
Cambridge University Hospital
Cambridge
Guys and St. Thomas Hospital
London
The Royal Free Hospital
London
Netherlands2 sites
Albert Schweitzer Hospital
Dordrecht
St. Antonius Hospital
Nieuwegein
About this study
Official title: ProspectIve, MuLti-Center Study to EvaLUate TreatMent of Subjects With OcclusivE Disease With a Novel PAcliTazel-CoatEd Angioplasty Balloon in Below-The-Knee (BTK) Arteries: a Post Market Clinical Study
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.
Read the 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
- Being tested
- StellarexTM 0.014" Over-The-Wire Drug-coated Angioplasty Balloon
- Keywords
- Critical Limb Ischemia, CLI, Claudication, PAD, BTK, Below The Knee
- Medical subject headings
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | StellarexTM 0.014 OTW Drug-coated Angioplasty Balloon (Stellarex Balloon) Receives: Combination Product: StellarexTM 0.014" Over-The-Wire Drug-coated Angioplasty Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (42)
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
Measured: 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
Measured: 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
Measured: 24 months
Rate of CD-TLR at 6, 12 and 24 months
Rate of CD-TLR
Measured: 6 months
Rate of CD-TLR at 6, 12 and 24 months
Rate of CD-TLR
Measured: 12 months
Rate of CD-TLR at 6, 12 and 24 months
Rate of CD-TLR
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, approximately 5 years
Rate of device or procedure related death at 30 days
Rate of device or procedure related death
Measured: 30 days
Rate of major target limb amputation at 6 months post-procedure
Rate of major target limb amputation
Measured: 6 months
Rate of major target limb amputation at 12 months post-procedure
Rate of major target limb amputation
Measured: 12 months
Rate of major target limb amputation at 24 months post-procedure
Rate of major target limb amputation
Measured: 24 months
Rate of clinically driven target vessel revascularization through 6 months
Rate of clinically driven target vessel revascularization
Measured: 6 months
Rate of clinically driven target vessel revascularization through 12 months
Rate of clinically driven target vessel revascularization
Measured: 12 months
Rate of clinically driven target vessel revascularization through 24 months
Rate of clinically driven target vessel revascularization
Measured: 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
Measured: 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
Measured: Through study completion, approximately 5 years
Change in waveforms/TcPO2 from pre-procedure to 30 days
Change in waveforms/TcPO2 from pre-procedure
Measured: 30 days
Change in waveforms/TcPO2 from pre-procedure to 6 months
Change in waveforms/TcPO2 from pre-procedure
Measured: 6 months
Change in waveforms/TcPO2 from pre-procedure to 12 months
Change in waveforms/TcPO2 from pre-procedure
Measured: 12 months
Change in waveforms/TcPO2 from pre-procedure to 24 months
Change in waveforms/TcPO2 from pre-procedure
Measured: 24 months
Change in ankle-brachial index (ABI) from pre-procedure to 30 days
Change in ankle-brachial index (ABI) from pre-procedure
Measured: 30 days
Change in ankle-brachial index (ABI) from pre-procedure to 6 months
Change in ankle-brachial index (ABI) from pre-procedure
Measured: 6 months
Change in ankle-brachial index (ABI) from pre-procedure to 12 months
Change in ankle-brachial index (ABI) from pre-procedure
Measured: 12 months
Change in ankle-brachial index (ABI) from pre-procedure to 24 months
Change in ankle-brachial index (ABI) from pre-procedure
Measured: 24 months
Change in toe pressures (TP) from pre-procedure to 30 days
Change in toe pressures (TP) from pre-procedure
Measured: 30 days
Change in toe pressures (TP) from pre-procedure to 6 months
Change in toe pressures (TP) from pre-procedure
Measured: 6 months
Change in toe pressures (TP) from pre-procedure to 12 months
Change in toe pressures (TP) from pre-procedure
Measured: 12 months
Change in toe pressures (TP) from pre-procedure to 24 months
Change in toe pressures (TP) from pre-procedure
Measured: 24 months
Change in Rutherford-Becker Classification (RCC) from pre-procedure to 30 days
Change in Rutherford-Becker Classification (RCC) from pre-procedure
Measured: 30 days
Change in Rutherford-Becker Classification (RCC) from pre-procedure to 6 months
Change in Rutherford-Becker Classification (RCC) from pre-procedure
Measured: 6 months
Change in Rutherford-Becker Classification (RCC) from pre-procedure to 12 months
Change in Rutherford-Becker Classification (RCC) from pre-procedure
Measured: 12 months
Change in Rutherford-Becker Classification (RCC) from pre-procedure to 24 months
Change in Rutherford-Becker Classification (RCC) from pre-procedure
Measured: 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.
Measured: 30 days
Change in EQ-5D from pre-procedure to 6 months
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.
Measured: 6 months
Change in EQ-5D from pre-procedure to 12 months
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.
Measured: 12 months
Change in EQ-5D from pre-procedure to 24 months
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start20 Apr 2018
- Primary completion23 Aug 2023
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectranetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gunnar Tepe, MD, Principal investigator, Institut für Diagnostische und Interventionelle Radiologie, RoMed Klinikum Rosenheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395236
- Sponsor's protocol ID
- D037012
- Acronym
- BTK PMS
- Status last verified
- Nov 2023
- First submitted
- 1 Dec 2017
- Last updated
- 24 Jan 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProspectIve, MuLti-Center Study to EvaLUate TreatMent of Subjects With OcclusivE Disease With a Novel PAcliTazel-CoatEd Angioplasty Balloon in Below-The-Knee (BTK) Arteries: a Post Market Clinical Study
- ClinicalTrials.gov ID
- NCT03395236
- Acronym / sponsor ID
- BTK PMS / D037012
- Conditions
- Peripheral Arterial Disease
- Keywords
- Critical Limb Ischemia, CLI, Claudication, PAD, BTK, Below The Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Spectranetics CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Combination Product: StellarexTM 0.014" Over-The-Wire Drug-coated Angioplasty BalloonStellarexTM 0.014 OTW Drug-coated Angioplasty Balloon (Stellarex Balloon) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StellarexTM 0.014" Over-The-Wire Drug-coated Angioplasty BalloonThe 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. | Combination product | Treatment |
Primary outcome
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
Time frame: 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.
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
Time frame: 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.
42 secondary outcomes
Major adverse event (MAE) rate at 6,12, and 24 months post index procedure
Time frame: 6 Months
Major adverse event (MAE) rate at 6,12, and 24 months post index procedure
Time frame: 12 months
Major adverse event (MAE) rate at 6,12, and 24 months post index procedure
Time frame: 24 months
Rate of CD-TLR at 6, 12 and 24 months
Time frame: 6 months
Rate of CD-TLR at 6, 12 and 24 months
Time frame: 12 months
Rate of CD-TLR at 6, 12 and 24 months
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
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
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
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
Time frame: through study completion, approximately 5 years
Rate of device or procedure related death at 30 days
Time frame: 30 days
Rate of major target limb amputation at 6 months post-procedure
Time frame: 6 months
Rate of major target limb amputation at 12 months post-procedure
Time frame: 12 months
Rate of major target limb amputation at 24 months post-procedure
Time frame: 24 months
Rate of clinically driven target vessel revascularization through 6 months
Time frame: 6 months
Rate of clinically driven target vessel revascularization through 12 months
Time frame: 12 months
Rate of clinically driven target vessel revascularization through 24 months
Time frame: 24 months
Lesion success:
Time frame: Through study completion, approximately 5 years
Technical success:
Time frame: Through study completion, approximately 5 years
Change in waveforms/TcPO2 from pre-procedure to 30 days
Time frame: 30 days
Change in waveforms/TcPO2 from pre-procedure to 6 months
Time frame: 6 months
Change in waveforms/TcPO2 from pre-procedure to 12 months
Time frame: 12 months
Change in waveforms/TcPO2 from pre-procedure to 24 months
Time frame: 24 months
Change in ankle-brachial index (ABI) from pre-procedure to 30 days
Time frame: 30 days
Change in ankle-brachial index (ABI) from pre-procedure to 6 months
Time frame: 6 months
Change in ankle-brachial index (ABI) from pre-procedure to 12 months
Time frame: 12 months
Change in ankle-brachial index (ABI) from pre-procedure to 24 months
Time frame: 24 months
Change in toe pressures (TP) from pre-procedure to 30 days
Time frame: 30 days
Change in toe pressures (TP) from pre-procedure to 6 months
Time frame: 6 months
Change in toe pressures (TP) from pre-procedure to 12 months
Time frame: 12 months
Change in toe pressures (TP) from pre-procedure to 24 months
Time frame: 24 months
Change in Rutherford-Becker Classification (RCC) from pre-procedure to 30 days
Time frame: 30 days
Change in Rutherford-Becker Classification (RCC) from pre-procedure to 6 months
Time frame: 6 months
Change in Rutherford-Becker Classification (RCC) from pre-procedure to 12 months
Time frame: 12 months
Change in Rutherford-Becker Classification (RCC) from pre-procedure to 24 months
Time frame: 24 months
Change in EQ-5D from pre-procedure to 30 days
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
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Tepe, MD principal investigator
Institut für Diagnostische und Interventionelle Radiologie, RoMed Klinikum Rosenheim
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing StellarexTM 0.014" Over-The-Wire Drug-coated Angioplasty Balloon in people with Peripheral Arterial Disease, run by Spectranetics Corporation at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, United Kingdom, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.