Peripheral Vascular DiseaseENDURENCT02129127
Drug-Coated Chocolate PTA Balloon in Patients With Peripheral Arterial Disease - The ENDURE Trial
A study testing Paclitaxel Coated Chocolate Balloon Angioplasty in people with Peripheral Vascular Disease, run by TriReme Medical, LLC at 2 sites in 2 countries.
Trial summary
This first-in-man study is to evaluate the Drug-Coated Chocolate (DCC) Balloon for percutaneous arterial angioplasty in patients with symptomatic peripheral arterial disease. The study focuses on acute device performance and peri-procedural safety and also seeks to further characterize the performance of the device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Paclitaxel Coated Chocolate Balloon Angioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2014to Apr 2017
- Phase
- Interventional
- 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
- Intermittent claudication or critical limb ischemia
- Atherosclerotic target lesion >70% stenosis
- Reference vessel diameter (RVD) between 2.0 and 6.0mm
- Angiographic evidence of distal run-off
- Target lesion length <150mm that consists of no more than two adjacent lesions( < 25mm apart) and is able to be completely covered with inflation of no more than two DCC devices
Who cannot join
- Acute limb ischemia or thrombolytic therapy
- Known and relevant allergies/hypersensitivities
- Known impaired renal function
- Known bleeding disorder
- Severe calcification at the target lesion
- Previous bypass or stent at, or proximal to, target vessel
Show all 9Show fewer
- Aneurysm in target limb
- Prior major limb amputation
- Use of a any of the following: re-entry device, atherectomy, laser or other ablation procedure, or cutting/scoring balloon at the target lesion; use of drug eluting stent, or non-study drug coated balloon in the target limb.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: First in Human Evaluation of the Drug-Coated Chocolate Balloon for Percutaneous Transluminal Revascularization of Infrainguinal Arterial Disease
This first-in-man study is to evaluate the Drug-Coated Chocolate (DCC) Balloon for percutaneous arterial angioplasty in patients with symptomatic peripheral arterial disease. The study focuses on acute device performance and peri-procedural safety and also seeks to further characterize the performance of the device.
Read the detailed description
This is a prospective, multi-center, single-arm study. Symptomatic lower extremity Peripheral Arterial Disease (PAD) patients presenting for endovascular revascularization will be enrolled in the study if they meet all entry criteria. The study will include patients from New Zealand and the European Union. The endpoints were designed to establish safety of the DCC and to identify long-term clinical benefits of this technology.
The patients treated in this study will be designated into the above the knee (ATK) follow-up schedule if they are treated with the DCC in the SFA or Popliteal vessels. This schedule calls for clinical visits with duplex ultrasounds at 1,6 and 12 months. Patients will be designated into the below the knee (BTK) follow-up schedule if they are treated with the DCC in the Peroneal, Anterior Tibial, Posterior Tibial or Pedal vessels. These patients will have clinical visits at 1, 3 and 6 months with duplex ultrasound at the 1 and 6 months visits only.
- Conditions
- Peripheral Vascular Disease
- Being tested
- Paclitaxel Coated Chocolate Balloon Angioplasty
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel Coated Chocolate Balloon AngioplastyDevice
Balloon Angioplasty with the Chocolate Balloon resulting in vessel dilatation and localized delivery of Paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| Drug Coated Chocolate | Experimental | Paclitaxel Coated Chocolate Balloon Angioplasty Receives: Device: Paclitaxel Coated Chocolate Balloon Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late Lumen Loss (LLL)
LLL is determined by assessing the difference between the minimum lumen diameter (MLD) immediately after treatment with the DCC and the MLD at angiographic follow-up. LLL will determined by the Angiographic Core Laboratory.
Measured: 3 Months (BTK) or 6 Months (ATK)
Secondary outcomes (6)
Device Success
This is defined as the percentage of procedures that accomplish less than 30% residual stenosis without flow-limiting dissection at target lesion after DCC treatment.
Measured: approx 1 hour
Technical Success
This is defined as the percentage of cases in which the DCC is able to be delivered to and inflated at the intended target lesion location successfully.
Measured: approx 1 hour
Device Related Adverse Events (AEs)
Occurrence and Severity of any DCC Related AEs will be analyzed
Measured: 30 days
Freedom from Target Lesion Revascularization (TLR)
This will calculate the number of patients who do not require a clinically indicated TLR. Clinically indicated TLR is defined as any repeat percutaneous intervention at the DCC target lesion or bypass surgery at the DCC target vessel performed for >50% restenosis or another complication of the target lesion
Measured: 30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only)
Amputation Free Survival
This is a composite endpoint which counts the number of patients who experience limb salvage. Patients will fail this endpoint if they undergo a major amputation (defined as unplanned amputation at or above the ankle) or if a procedure related death occurs.
Measured: 30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only)
Patency
The percentage of cases in which the treated lesion is patent. Patency is demonstrated by a Peak Systolic Velocity ratio <2.5 at the target lesion assessed on Duplex Ultrasound without the need for re-intervention.
Measured: 6 Months / 12 Months (ATK only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2015
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriReme Medical, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Holden, MD, Principal investigator, Auckland City HospitalThomas Zeller, MD, Principal investigator, Universitats Herzzentrum Bad Krozingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129127
- Sponsor's protocol ID
- CLP004
- Acronym
- ENDURE
- Status last verified
- Apr 2017
- First submitted
- 30 Apr 2014
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Human Evaluation of the Drug-Coated Chocolate Balloon for Percutaneous Transluminal Revascularization of Infrainguinal Arterial Disease
- ClinicalTrials.gov ID
- NCT02129127
- Acronym / sponsor ID
- ENDURE / CLP004
- Conditions
- Peripheral Vascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- TriReme Medical, LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 2 May 2014 (estimated)
- 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.
This first-in-man study is to evaluate the Drug-Coated Chocolate (DCC) Balloon for percutaneous arterial angioplasty in patients with symptomatic peripheral arterial disease. The study focuses on acute device performance and peri-procedural safety and also seeks to further characterize the performance of the device.
Detailed description
This is a prospective, multi-center, single-arm study. Symptomatic lower extremity Peripheral Arterial Disease (PAD) patients presenting for endovascular revascularization will be enrolled in the study if they meet all entry criteria. The study will include patients from New Zealand and the European Union. The endpoints were designed to establish safety of the DCC and to identify long-term clinical benefits of this technology.
The patients treated in this study will be designated into the above the knee (ATK) follow-up schedule if they are treated with the DCC in the SFA or Popliteal vessels. This schedule calls for clinical visits with duplex ultrasounds at 1,6 and 12 months. Patients will be designated into the below the knee (BTK) follow-up schedule if they are treated with the DCC in the Peroneal, Anterior Tibial, Posterior Tibial or Pedal vessels. These patients will have clinical visits at 1, 3 and 6 months with duplex ultrasound at the 1 and 6 months visits only.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug Coated Chocolate | Experimental | Device: Paclitaxel Coated Chocolate Balloon AngioplastyPaclitaxel Coated Chocolate Balloon Angioplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Intermittent claudication or critical limb ischemia
- Atherosclerotic target lesion >70% stenosis
- Reference vessel diameter (RVD) between 2.0 and 6.0mm
- Angiographic evidence of distal run-off
- Target lesion length <150mm that consists of no more than two adjacent lesions( < 25mm apart) and is able to be completely covered with inflation of no more than two DCC devices
Key exclusion criteria (9 listed)
- Acute limb ischemia or thrombolytic therapy
- Known and relevant allergies/hypersensitivities
- Known impaired renal function
- Known bleeding disorder
- Severe calcification at 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 |
|---|---|---|
| Paclitaxel Coated Chocolate Balloon AngioplastyBalloon Angioplasty with the Chocolate Balloon resulting in vessel dilatation and localized delivery of Paclitaxel | Device | Drug Coated Chocolate |
Primary outcome
Late Lumen Loss (LLL)
Time frame: 3 Months (BTK) or 6 Months (ATK)
LLL is determined by assessing the difference between the minimum lumen diameter (MLD) immediately after treatment with the DCC and the MLD at angiographic follow-up. LLL will determined by the Angiographic Core Laboratory.
6 secondary outcomes
Device Success
Time frame: approx 1 hour
Technical Success
Time frame: approx 1 hour
Device Related Adverse Events (AEs)
Time frame: 30 days
Freedom from Target Lesion Revascularization (TLR)
Time frame: 30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only)
Amputation Free Survival
Time frame: 30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only)
Patency
Time frame: 6 Months / 12 Months (ATK only)
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 14 Apr 2017.
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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.
Andrew Holden, MD principal investigator
Auckland City Hospital
Thomas Zeller, MD principal investigator
Universitats Herzzentrum Bad Krozingen
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel Coated Chocolate Balloon Angioplasty in people with Peripheral Vascular Disease, run by TriReme Medical, LLC at 2 sites in 2 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 5 inclusion and 9 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 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, New Zealand. 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?
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?
Late Lumen Loss (LLL) (time frame: 3 Months (BTK) or 6 Months (ATK)). 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 14 Apr 2017.