Peripheral Arterial DiseaseHEROES-DCBNCT02812966
Lutonix or Inpact for tHE tReatment Of fEmeropopliteal Stenosis - Drug Coated Balloon
A study testing Lutonix and IN.PACT in people with Peripheral Arterial Disease, run by Wake Forest University Health Sciences at 6 sites in United States.
Trial summary
Investigators hypothesize in patients presenting with significant peripheral arterial disease with clinical indications for treatment with angioplasty, there will be a difference in 12 month patency between the subjects with Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter and IN.PACT… 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?
- Lutonix and IN.PACT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2016to 2 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient is willing and able to provide informed consent, willing and agrees to comply with regular follow up visits, testing, medication regimen compliance any another treatments deemed necessary for treatment of vascular disease.
- Male or non-pregnant female
- Age greater >=18 years of age
- Patients with moderate to severe claudication or ischemic rest pain as defined by Rutherford 2-4 class symptoms
- >=1 tibial run-off vessel at baseline
- Angiographic criteria
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- >=70% stenosis (via visual angiographic estimate in the superficial femoral artery and/or popliteal arteries as appropriate)
- 4-7 mm vessel diameter
- <=15 cm for planned treatment segment length.
- Planned treatment segments are to no further proximal than 1 cm from the bifurcation of the common femoral artery and no further distal than the 1 cm above the tibioperoneal trunk.
- Lesions treated within the target vessel are either De Novo lesions or not previously stented restenotic segments of the superficial femoral artery and/or popliteal artery that are greater than 90 days from prior angioplasty procedure
- If the target vessel was previously stented the treated lesion must be at least 3 cm from the previously placed stent
- Lesion must be able to be treated with either drug coated balloon device based on the sizes specifications of both devices
- Successful, uncomplicated crossing must be possible within the treated lesion either with or without a crossing device
- Inflow artery must be free from significant occlusive disease (< 50%) as confirmed by visual estimation by angiography otherwise the inflow artery must be treated beforehand.
- At least 1 patent vessel outflow from the target vessel treated must be present by angiography
Who cannot join
- Unable to meet clinical criteria to have peripheral angioplasty and follow-up treatment (lab values and pregnancy test)
- Contra-indicated to either drug coated balloon
- < 18 years of age at time of consent and/or index procedure
- Pregnant or breastfeeding
- In-stent restenosis within the target lesion
- Previously stented target lesion/vessel.
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- Target lesion/vessel previously treated with drug-coated balloon <12 months prior to randomization/enrollment.
- Perforated vessel as evidenced by extravasation of contrast media prior to consent or enrollment.
- Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention <=30 days of consent or randomization.
- Presence of aneurysm in the target vessel.
- Major amputation in the target limb.
- Subjects who have undergone prior surgery of the superficial femoral artery/proximal popliteal artery in the target limb to treat atherosclerotic disease.
- Use of atherectomy, laser or other debulking devices in the target limb superficial femoral artery/proximal popliteal artery during the index procedure.
- Acute ischemia and/or acute thrombosis of the superficial femoral artery/proximal popliteal artery prior to consent or randomization.
- Known hypersensitivity or contraindication to contrast dye that, in the opinion of the local investigator, cannot be adequately pre-medicated.
- Known hypersensitivity/allergy to the investigational stent system or protocol related therapies.
- On dialysis or on an immunosuppressant therapy.
- Concomitant renal failure (including serum creatinine >2.0 mg/dL.)
- Occurrence of myocardial infarction or cerebrovascular accident <=6 months prior to consent.
- Platelet count <80,000 mm3 or >600,000 mm3 or history of bleeding diathesis.
- Unstable angina pectoris at the time of consent or randomization.
- Septicemia at the time of consent or randomization.
- Moderate to severely calcified lesions.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429
Edward Hospital
Naperville, Illinois, 60540
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Prairie Education and Research Collaborative
Springfield, Illinois, 62701
About this study
Investigators hypothesize in patients presenting with significant peripheral arterial disease with clinical indications for treatment with angioplasty, there will be a difference in 12 month patency between the subjects with Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter and IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter.
Read the detailed description
Investigators hypothesize in patients presenting with significant peripheral arterial disease with clinical indications for treatment with angioplasty, there will be a difference in the 12 month patency (defined as peak systolic velocity ratio <=2.4 at 12 month follow-up visit with no target lesion revascularization or target lesion bypass) between the subjects with Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter and IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter. Investigators will also assess and compare target lesion revascularization rates, safety profiles, adverse events, healthcare costs, and healthcare utilization.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Lutonix, IN.PACT
- Keywords
- peripheral arterial disease, drug coated balloon
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LutonixDevice
Drug Coated Balloons
IN.PACTDevice
Drug Coated Balloons
| Study group | Role | What they receive |
|---|---|---|
| Lutonix Drug Coated Balloon | Active comparator | Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter Receives: Device: Lutonix |
| IN.PACT Drug Coated Balloon | Active comparator | IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter Receives: Device: IN.PACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency (Peak Systolic Velocity Ratio<=2.4)
Peak systolic velocity ratio <=2.4 (by duplex ultrasound scanning) with no target lesion revascularization or target lesion bypass
Measured: 12 months
Secondary outcomes (1)
Target Lesion Revascularization Rate
To examine, describe and compare/contrast within and between Drug Coated Balloon groups.
- Target lesion revascularization rate
- Safety event rate
- Healthcare utilization costs
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 posted24 Jun 2016 (estimated)
- Study startApr 2016
- Primary completion2 Dec 2019
- Study completion2 Dec 2019
Why it stopped: new FDA information regarding drug-coated balloons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaafer Golzar, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812966
- Sponsor's protocol ID
- C5000163
- Acronym
- HEROES-DCB
- Status last verified
- Jul 2024
- First submitted
- 21 Jun 2016
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lutonix or Inpact for tHE tReatment Of fEmeropopliteal Stenosis - Drug Coated Balloon
- ClinicalTrials.gov ID
- NCT02812966
- Acronym / sponsor ID
- HEROES-DCB / C5000163
- Conditions
- Peripheral Arterial Disease
- Keywords
- peripheral arterial disease, drug coated balloon
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: new FDA information regarding drug-coated balloons
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- 2 Dec 2019 (actual)
- Study completion
- 2 Dec 2019 (actual)
- First posted
- 24 Jun 2016 (estimated)
- Results
- Posted 30 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators hypothesize in patients presenting with significant peripheral arterial disease with clinical indications for treatment with angioplasty, there will be a difference in 12 month patency between the subjects with Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter and IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter.
Detailed description
Investigators hypothesize in patients presenting with significant peripheral arterial disease with clinical indications for treatment with angioplasty, there will be a difference in the 12 month patency (defined as peak systolic velocity ratio <=2.4 at 12 month follow-up visit with no target lesion revascularization or target lesion bypass) between the subjects with Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter and IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter. Investigators will also assess and compare target lesion revascularization rates, safety profiles, adverse events, healthcare costs, and healthcare utilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lutonix Drug Coated Balloon | Active comparator | Device: LutonixLutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter |
| IN.PACT Drug Coated Balloon | Active comparator | Device: IN.PACTIN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patient is willing and able to provide informed consent, willing and agrees to comply with regular follow up visits, testing, medication regimen compliance any another treatments deemed necessary for treatment of vascular disease.
- Male or non-pregnant female
- Age greater >=18 years of age
- Patients with moderate to severe claudication or ischemic rest pain as defined by Rutherford 2-4 class symptoms
- >=1 tibial run-off vessel at baseline
Key exclusion criteria (23 listed)
- Unable to meet clinical criteria to have peripheral angioplasty and follow-up treatment (lab values and pregnancy test)
- Contra-indicated to either drug coated balloon
- < 18 years of age at time of consent and/or index procedure
- Pregnant or breastfeeding
- In-stent restenosis within the target lesion
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 |
|---|---|---|
| LutonixDrug Coated Balloons | Device | Lutonix Drug Coated Balloon |
| IN.PACTDrug Coated Balloons | Device | IN.PACT Drug Coated Balloon |
Primary outcome
Primary Patency (Peak Systolic Velocity Ratio<=2.4)
Time frame: 12 months
Peak systolic velocity ratio <=2.4 (by duplex ultrasound scanning) with no target lesion revascularization or target lesion bypass
1 secondary outcome
Target Lesion Revascularization Rate
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jaafer Golzar, MD principal investigator
Wake Forest University Health Sciences
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lutonix and IN.PACT in people with Peripheral Arterial Disease, run by Wake Forest University Health Sciences at 6 sites in United States.
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 16 inclusion and 23 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: stopped early, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Patency (Peak Systolic Velocity Ratio<=2.4) (time frame: 12 months). 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 8 Oct 2024.