AngioplastyiliCoNCT05192616
Safety and Effectiveness Evaluation of iCover Covered Stent for the Treatment of the Aorto-iliac Occlusive Disease
An observational study of Angioplasty and Peripheral Arterial Disease, run by iVascular S.L.U. at 18 sites in 4 countries.
Trial summary
The objective of this prospective, multi-center, non-randomized, single-arm observational study is to evaluate the safety and the efficacy of the iCover covered stent over a 24-month follow-up period for the treatment of de novo iliac occlusive lesions, defined by a significant vessel stenosis ≥70%, in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angioplasty, Peripheral Arterial Disease, Iliac Artery Disease
- What is being tested?
- Covered stent implantation
- Type of treatment
- Medical device
- How many people
- 241 participants
- Where
- 18 sitesin 4 countries
- Study dates
- 27 Apr 2022to 30 Sep 2026
- Phase
- Observational
- 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
Study population: Patients with symptomatic arteriopathy of the lower limbs (Rutherford class 2 to 5). Patients with de novo atheromatous aorto-iliac lesions. According to the incidence of TASC II lesions, approximately 70% of the patients will be classified as TASC II A or B lesions, while the other 30% will be classified as TASC II C or D lesions.
Who may be able to join
- ≥ 18 years of age
- Rutherford clinical stage 2 to 5
- Significant (≥70%) stenosis of atheromatous iliac lesions evidenced by duplex scan, MRI CT angiography or arteriography
- De novo atheromatous lesion of the aortoiliac segment
- Patient informed about the study and collection of the patient's informed consent agreement Exclusion criteria
- Subjects will not be eligible to participate in the study if any of the following conditions are present in the subject:
Show all 21Show fewer
- Protected adult patients, guardianship, curatorship, safeguard of justice
- Woman with possibility of pregnancy
- Patient with asymptomatic atheromatous lesions
- Patient with inflow lesion in the infrarenal aorta
- Patient treated with Covered endovascular reconstruction of aortic bifurcation (CERAB reconstruction)
- Acute ischemia or acute thrombosis
- Non-atherosclerotic disease
- History of coagulopathy
- Severe comorbidities with life expectancy <2 years
- Contraindication to taking antiplatelet aggregation therapy (aspirin or clopidogrel). The patient must be able to take an antiplatelet aggregation for at least 3 months after the procedure
- Patient participating in another clinical study which may interfere with the results
- Comorbidity or any reason which, according to the investigator, could limit the participation, the patient's adherence with the follow-up or the scientific integrity of the study
- Lesion near or adjacent to an aneurysm
- Inability to follow-up during the investigation
- Patient objection to participate in the investigation
Who cannot join
None listed.
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
France5 sites
Centre Hospitalier Universitaire de Brest
Brest
CHU Pitié Salpêtrière
Paris
Hôpital Paris Saint Joseph
Paris
Hôpital privé Saint-Martin
Pessac
Hôpital privé Villeneuve d'Ascq
Villeneuve-d'Ascq
Germany5 sites
Herzzentrum Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, 79189
KEH Berlin
Berlin
MVZ Kaiserslautern
Kaiserslautern, Rhineland-Palatinate, 67657
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103
Imland Klinik Rendsburg
Rendsburg
Belgium4 sites
Onze Lieve Vrouw Aalst
Aalst
Imelda Bonheiden
Bonheiden
Az Sint Blasius Dendermonde
Dendermonde
ZOL Genk
Genk
Spain4 sites
Hospital de Santa Creu i Sant Pau
Barcelona
Hospital Universitari Germans Trias i Pujol
Barcelona
Hospital de Cruces
Bilbao
Hospital Parc Taulí
Sabadell
About this study
Official title: Prospective, Multicenter, Non-randomized, Single-arm Observational Study to Evaluate Safety and Effectiveness of iCover Covered Stent for the Treatment of the Aorto-iliac Occlusive Disease
The objective of this prospective, multi-center, non-randomized, single-arm observational study is to evaluate the safety and the efficacy of the iCover covered stent over a 24-month follow-up period for the treatment of de novo iliac occlusive lesions, defined by a significant vessel stenosis ≥70%, in patients with symptomatic arteriopathy of the lower limbs (Rutherford class 2 to 5).
Read the detailed description
This is a prospective, single-arm, multinational, and multicenter study conducted to evaluate the safety and efficacy of the iCover covered stent for the treatment of de novo iliac occlusive lesions (common and/or external iliac arteries) in patients with symptomatic lower limb arteriopathy. The primary endpoint of the study is primary patency, defined as the absence of restenosis in the target lesion over a 12-month follow-up period in patients who did not undergo a reintervention on the target lesion. Restenosis is defined as a reduction in the luminal diameter of more than 50%, assessed either by duplex ultrasound (considered as a peak systolic velocity index ≥ 2.4 at the target lesion) or by angio-CT (multiplanar reconstruction). Secondary endpoints include: technical and procedural success rate, freedom from all major adverse events, incidence of procedure- or device-related major local complications at the treated lesion, rate of SAEs, major amputation rate at the target limb, primary sustained clinical improvement (improvement in Rutherford classification), primary and secondary patency rates, TLR and TVR rates, and changes in ABI, the Walking Impairment Questionnaire, and the EQ-5D questionnaire from baseline.
- Conditions
- Angioplasty, Peripheral Arterial Disease, Iliac Artery Disease, Covered Stent, Aorto-Iliac Atherosclerosis
- Being tested
- Covered stent implantation
- 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.
Covered stent implantationDevice
Percutaneous transluminal angioplasty (PTA) with iCover covered stent for the treatment of de novo aorto-iliac occlusive lesions
| Study group | Role | What they receive |
|---|---|---|
| iCover covered stent | Percutaneous transluminal angioplasty (PTA) Receives: Device: Covered stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency
The primary patency, defined as the absence of restenosis in the target lesion over the 12-month follow-up period in patients who did not undergo a reintervention on the target lesion.
Measured: 12 months after index procedure.
Secondary outcomes (14)
Technical success rate
Technical success rate, defined as the ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30% after iCover stent graft insertion. Outcomes will be computed as the percentage of lesions treated at the end of the procedure.
Measured: Day 0.
Procedural success rate
Procedural success rate, defined as technical success and no complications during the procedure including general and local complications as defined in the protocol. Outcomes will be computed as the percentage of patients at the end of the procedure.
Measured: Day 0.
Freedom from All Major Adverse Event (MAEs)
MAEs are described as All-Cause Mortality post-procedure, Target Lesion Revascularization (TLR) post-procedure and Major Amputation of the Target Limb post-procedure (amputations above the ankle of the target leg).
Measured: 1, 6, 12, 24 months after index procedure.
Incidence of Procedure- or Device- related Major Local Complications
Incidence of Procedure- or Device- related Major Local Complications at the treated lesion or Puncture Site up to 30 days post-procedure. Major Local Complications include: Iliac arterial rupture, retroperitoneal hematoma, thrombosis of the iliac axis on the ipsilateral side, need for surgery to achieve hemostasis, bleeding with loss of more than 2 g/ dL of hemoglobin, false aneurysm at the puncture site, preventing resumption of walking at 24 hours or appearance of ischemia on the ipsilateral side.
Measured: Up to 30 days after index procedure.
Rates of Serious Adverse Events (SAEs)
Rates of SAEs, including both related and unrelated events. SAEs will be categorized as related or unrelated to the procedure/device based on adjudication by an Independent Clinical Events Committee.
Measured: 1, 6, 12, 24 months after index procedure.
Major amputation at target limb rate
Percentage of patients with amputations above the ankle of the target leg will be counted.
Measured: 1, 6, 12, 24 months after index procedure.
Primary sustained clinical improvement
Primary sustained clinical improvement defined as a sustained upward shift of 1 category of the Rutherford classification for patients with claudication, and by wound healing and rest pain resolution for patients in critical limb ischemia, without the need for repeated target lesion revascularization in surviving patients.
Measured: 1, 6, 12, 24 months after index procedure.
Primary patency rates
Primary patency rates, defined as the lack of restenosis without reintervention of the target lesion. Restenosis is defined as a reduction in the luminal diameter of more than 50%, determined by either, duplex ultrasound examination considered as a peak systolic velocity index ≥ 2.4 at the target lesion, or by angio-CT (multiplanar reconstruction). In case of death, the vessel is considered as patent as long as no restenosis was detected during the last visit before the patient died. Outcomes will be computed as the percentage of lesions (Time frame: 6, 24 months after index procedure).
Measured: 6 and 24 months after index procedure.
Secondary patency rates
Secondary patency rates, defined as the patency of the stent following an endovascular or surgical reintervention due to significant in-stent restenosis or occlusion. Outcomes computed as percentage of lesions.
Measured: 6, 12, 24 months after index procedure.
Target lesion revascularization (TLR) rate
Target lesion revascularization (TLR) rate, defined as the need for repeated procedures (endovascular or surgical) due to a problem arising from the lesion initially treated in surviving patients with preserved limbs. Outcomes will be computed as the percentage of lesions.
Measured: 1, 6, 12, 24 months after index procedure.
Target vessel revascularization (TVR) rate
Target vessel revascularization (TVR) rate, defined as the need for repeated procedures (endovascular or surgical) due to a problem arising remote from the vessel initially treated in surviving patients with preserved limbs. Outcomes will be computed as the percentage of lesions.
Measured: 1, 6, 12, 24 months after index procedure.
Change in Ankle-Brachial Index (ABI) from baseline
Change in ABI from baseline.
Measured: 1, 6, 12, 24 months post-procedure.
Change in Walking Impairment Questionnaire from baseline
The Walking Impairment Questionnaire values will be recorded and compared to the baseline values. This questionnaire is a validated tool to assess walking capability in patients with Peripheral Arterial Disease in different situations.
Measured: 1, 6, 12, 24 months post-procedure.
Change in quality of life from baseline
Change in quality of life from baseline, as measured by EQ-5D. The EQ-5D Questionnaire values will be recorded and compared to the baseline values. It is a validated questionnaire to measure the quality of life based on 5 different parameters. Worst possible score in this study would be 0, best possible score would be 1. In addition, the patient indicates her/his current health on an analog scale from 0 (worst) to 100 (best).
Measured: 1, 6, 12, 24 months post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start27 Apr 2022
- Primary completion30 Jun 2025
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngioplastyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- iVascular S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192616
- Sponsor's protocol ID
- iliCo Study
- Acronym
- iliCo
- Status last verified
- Nov 2026
- First submitted
- 14 Dec 2021
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Non-randomized, Single-arm Observational Study to Evaluate Safety and Effectiveness of iCover Covered Stent for the Treatment of the Aorto-iliac Occlusive Disease
- ClinicalTrials.gov ID
- NCT05192616
- Acronym / sponsor ID
- iliCo / iliCo Study
- Conditions
- Angioplasty, Peripheral Arterial Disease, Iliac Artery Disease, Covered Stent, Aorto-Iliac Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- iVascular S.L.U.Industry (pharma, biotech, devices)
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 14 Jan 2022 (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, non-randomized, single-arm observational study is to evaluate the safety and the efficacy of the iCover covered stent over a 24-month follow-up period for the treatment of de novo iliac occlusive lesions, defined by a significant vessel stenosis ≥70%, in patients with symptomatic arteriopathy of the lower limbs (Rutherford class 2 to 5).
Detailed description
This is a prospective, single-arm, multinational, and multicenter study conducted to evaluate the safety and efficacy of the iCover covered stent for the treatment of de novo iliac occlusive lesions (common and/or external iliac arteries) in patients with symptomatic lower limb arteriopathy. The primary endpoint of the study is primary patency, defined as the absence of restenosis in the target lesion over a 12-month follow-up period in patients who did not undergo a reintervention on the target lesion. Restenosis is defined as a reduction in the luminal diameter of more than 50%, assessed either by duplex ultrasound (considered as a peak systolic velocity index ≥ 2.4 at the target lesion) or by angio-CT (multiplanar reconstruction). Secondary endpoints include: technical and procedural success rate, freedom from all major adverse events, incidence of procedure- or device-related major local complications at the treated lesion, rate of SAEs, major amputation rate at the target limb, primary sustained clinical improvement (improvement in Rutherford classification), primary and secondary patency rates, TLR and TVR rates, and changes in ABI, the Walking Impairment Questionnaire, and the EQ-5D questionnaire from baseline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iCover covered stent | – | Device: Covered stent implantationPercutaneous transluminal angioplasty (PTA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic arteriopathy of the lower limbs (Rutherford class 2 to 5). Patients with de novo atheromatous aorto-iliac lesions. According to the incidence of TASC II lesions, approximately 70% of the patients will be classified as TASC II A or B lesions, while the other 30% will be classified as TASC II C or D lesions.
Key inclusion criteria (21 listed)
- ≥ 18 years of age
- Rutherford clinical stage 2 to 5
- Significant (≥70%) stenosis of atheromatous iliac lesions evidenced by duplex scan, MRI CT angiography or arteriography
- De novo atheromatous lesion of the aortoiliac segment
- Patient informed about the study and collection of the patient's informed consent agreement Exclusion criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Covered stent implantationPercutaneous transluminal angioplasty (PTA) with iCover covered stent for the treatment of de novo aorto-iliac occlusive lesions | Device | iCover covered stent |
Primary outcome
Primary Patency
Time frame: 12 months after index procedure.
The primary patency, defined as the absence of restenosis in the target lesion over the 12-month follow-up period in patients who did not undergo a reintervention on the target lesion.
14 secondary outcomes
Technical success rate
Time frame: Day 0.
Procedural success rate
Time frame: Day 0.
Freedom from All Major Adverse Event (MAEs)
Time frame: 1, 6, 12, 24 months after index procedure.
Incidence of Procedure- or Device- related Major Local Complications
Time frame: Up to 30 days after index procedure.
Rates of Serious Adverse Events (SAEs)
Time frame: 1, 6, 12, 24 months after index procedure.
Major amputation at target limb rate
Time frame: 1, 6, 12, 24 months after index procedure.
Primary sustained clinical improvement
Time frame: 1, 6, 12, 24 months after index procedure.
Primary patency rates
Time frame: 6 and 24 months after index procedure.
Secondary patency rates
Time frame: 6, 12, 24 months after index procedure.
Target lesion revascularization (TLR) rate
Time frame: 1, 6, 12, 24 months after index procedure.
Target vessel revascularization (TVR) rate
Time frame: 1, 6, 12, 24 months after index procedure.
Change in Ankle-Brachial Index (ABI) from baseline
Time frame: 1, 6, 12, 24 months post-procedure.
Change in Walking Impairment Questionnaire from baseline
Time frame: 1, 6, 12, 24 months post-procedure.
Change in quality of life from baseline
Time frame: 1, 6, 12, 24 months post-procedure.
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 5 Nov 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angioplasty and Peripheral Arterial Disease, run by iVascular S.L.U. at 18 sites in 4 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 21 inclusion and 0 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France, Germany, Belgium, Spain. 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?
Primary Patency (time frame: 12 months after index procedure.). 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 5 Nov 2026.