Peripheral Artery Disease (PAD)SELECTNCT06605209
Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)
A study testing Peripheral Balloon-Expandable Covered Stent System in people with Peripheral Artery Disease (PAD), run by Zhejiang Zylox Medical Device Co., Ltd. at 1 site in China.
Trial summary
This is a prospective, multi-center, single-arm clinical trial to evaluate the Peripheral Balloon-Expandable Covered Stent System for treating stenosis and/or occlusion in the common and external iliac arteries. The safety and effectiveness of the stent system will be compared to pre-set performance goals. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Artery Disease (PAD)
- What is being tested?
- Peripheral Balloon-Expandable Covered Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 8 Nov 2024to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 18 to 80 years, regardless of sex;
- Participants diagnosed with atherosclerotic disease of the common iliac or external iliac artery;
- Participants with a Rutherford classification of 2 to 4 for the target limb;
- Participants or their legal representatives must be able to understand the study's purpose, demonstrate adequate compliance with the study protocol, and sign the informed consent form.
Who cannot join
- Pregnant or planning to become pregnant, or breastfeeding women;
- Participants who have previously had a vascular graft implanted in the native iliac artery;
- Participants who have had a stroke or myocardial infarction within 3 months prior to enrollment;
- Participants with known uncorrectable bleeding disorders or severe coagulation abnormalities (PT or APTT ≥ 2 times the upper limit of normal; or platelet count \< 80×10^9/L);
- Participants with serum creatinine ≥ 221 μmol/L (2.5 mg/dL) or currently undergoing dialysis;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal;
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- Severe anemia (hemoglobin level \< 60.0 g/L);
- Participants known to be allergic or intolerant to cobalt-based alloys, expanded polytetrafluoroethylene (ePTFE), aspirin, clopidogrel, heparin, rivaroxaban, paclitaxel, contrast agents, or other study materials and medications;
- Participants who have undergone vascular intervention within 30 days prior to surgery or who plan to undergo vascular intervention within 30 days following surgery;
- Participants who have received intra-arterial thrombolysis treatment in the target vessel within 14 days prior to enrollment;
- Participants with significant organ dysfunction or other severe conditions that may lead to non-compliance with the study protocol, affect data interpretation, or have a life expectancy insufficient to complete the clinical trial;
- Participants currently involved in a clinical trial of investigational drugs, biologics, or medical devices;
- Other conditions that, in the investigator's opinion, make the participant unsuitable for the clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Medical Centre, Chinese PLA General Hospital
Beijing, Beijing Municipality, 100000
Wei Guo, MD, +86 010-66938349, pla301dml@vip.sina.com
About this study
Official title: A Prospective, Multi-Center, Non-Randomized, Single-Arm Study Evaluating the Peripheral Balloon-Expandable Covered Stent System for the Treatment of Stenosis and/or Occlusive Lesions in the Common and External Iliac Arteries.
This is a prospective, multi-center, single-arm clinical trial to evaluate the Peripheral Balloon-Expandable Covered Stent System for treating stenosis and/or occlusion in the common and external iliac arteries. The safety and effectiveness of the stent system will be compared to pre-set performance goals. All treated subjects will have follow-up visits at discharge, and at 1, 6, 12, 24, and 36 months after the procedure.
- Conditions
- Peripheral Artery Disease (PAD)
- Being tested
- Peripheral Balloon-Expandable Covered Stent System
- Keywords
- Covered Stent, iliac artery
- 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.
Peripheral Balloon-Expandable Covered Stent SystemDevice
The intervention in this clinical trial involves the Peripheral Balloon-Expandable Covered Stent System. This stent system is specifically designed for the treatment of stenosis and/or occlusion in the common and external iliac arteries.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral Balloon-Expandable Covered Stent System Group | Experimental | This arm of the study involves the use of the Peripheral Balloon-Expandable Covered Stent System. The intervention consists of implanting this stent system into the common and/or external iliac arteries of participants who have been diagnosed with stenosis and/or occlusion. The stent system is designed to be balloon-expandable and covered, providing a means to treat arterial blockages.
Participants in this arm will undergo the stent implantation procedure, followed by scheduled follow-up visits at discharge, and at 1, 6, 12, 24, and 36 months post-procedure. During these visits, the safety and effectiveness of the stent system will be assessed based on predefined performance goals, including clinical outcomes and any adverse events related to the stent. Receives: Device: Peripheral Balloon-Expandable Covered Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary patency
Primary patency of target lesion at 12-months assessed by duplex ultrasound and adjudicated by an independent core laboratory
Measured: 12 months
Secondary outcomes (2)
Major Adverse Event
Percentage of study subjects experiencing a major adverse event (MAE) defined as: device or procedure-related death, myocardial infarction (MI), target lesion revascularization (TLR) or major amputation of the target limb.
Measured: 36 months
Secondary Patency
The secondary patency of target lesion at 6, 12, 24, and 36 Months assessed by duplex ultrasound and adjudicated by an independent core laboratory
Measured: 6, 12, 24, and 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start8 Nov 2024
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery Disease (PAD)Studies 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605209
- Sponsor's protocol ID
- ZRD-11
- Acronym
- SELECT
- Status last verified
- Nov 2024
- First submitted
- 12 Sep 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Non-Randomized, Single-Arm Study Evaluating the Peripheral Balloon-Expandable Covered Stent System for the Treatment of Stenosis and/or Occlusive Lesions in the Common and External Iliac Arteries.
- ClinicalTrials.gov ID
- NCT06605209
- Acronym / sponsor ID
- SELECT / ZRD-11
- Conditions
- Peripheral Artery Disease (PAD)
- Keywords
- Covered Stent, iliac artery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 20 Sep 2024 (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.
This is a prospective, multi-center, single-arm clinical trial to evaluate the Peripheral Balloon-Expandable Covered Stent System for treating stenosis and/or occlusion in the common and external iliac arteries. The safety and effectiveness of the stent system will be compared to pre-set performance goals. All treated subjects will have follow-up visits at discharge, and at 1, 6, 12, 24, and 36 months after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripheral Balloon-Expandable Covered Stent System Group | Experimental | Device: Peripheral Balloon-Expandable Covered Stent SystemThis arm of the study involves the use of the Peripheral Balloon-Expandable Covered Stent System. The intervention consists of implanting this stent system into the common and/or external iliac arteries of participants who have been diagnosed with stenosis and/or occlusion. The stent system is designed to be balloon-expandable and covered, providing a means to treat arterial blockages. Participants in this arm will undergo the stent implantation procedure, followed by scheduled follow-up visits at discharge, and at 1, 6, 12, 24, and 36 months post-procedure. During these visits, the safety and effectiveness of the stent system will be assessed based on predefined performance goals, including clinical outcomes and any adverse events related to the stent. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants aged 18 to 80 years, regardless of sex;
- Participants diagnosed with atherosclerotic disease of the common iliac or external iliac artery;
- Participants with a Rutherford classification of 2 to 4 for the target limb;
- Participants or their legal representatives must be able to understand the study's purpose, demonstrate adequate compliance with the study protocol, and sign the informed consent form.
Key exclusion criteria (13 listed)
- Pregnant or planning to become pregnant, or breastfeeding women;
- Participants who have previously had a vascular graft implanted in the native iliac artery;
- Participants who have had a stroke or myocardial infarction within 3 months prior to enrollment;
- Participants with known uncorrectable bleeding disorders or severe coagulation abnormalities (PT or APTT ≥ 2 times the upper limit of normal; or platelet count \< 80×10^9/L);
- Participants with serum creatinine ≥ 221 μmol/L (2.5 mg/dL) or currently undergoing dialysis;
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 |
|---|---|---|
| Peripheral Balloon-Expandable Covered Stent SystemThe intervention in this clinical trial involves the Peripheral Balloon-Expandable Covered Stent System. This stent system is specifically designed for the treatment of stenosis and/or occlusion in the common and external iliac arteries. | Device | Peripheral Balloon-Expandable Covered Stent System Group |
Primary outcome
primary patency
Time frame: 12 months
Primary patency of target lesion at 12-months assessed by duplex ultrasound and adjudicated by an independent core laboratory
2 secondary outcomes
Major Adverse Event
Time frame: 36 months
Secondary Patency
Time frame: 6, 12, 24, and 36 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral Balloon-Expandable Covered Stent System in people with Peripheral Artery Disease (PAD), run by Zhejiang Zylox Medical Device Co., Ltd. at 1 site in China.
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 4 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: looking for participants now, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Guo, MD (+86 010-66938349, pla301dml@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary patency (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 4 Dec 2024; AzTrials last refreshed its copy on 26 Oct 2026.