Aorto-Iliac Occlusive DiseaseNCT03824730
Endovascular Treatment of Aorto-iliac Occlusions
An observational study of Aorto-Iliac Occlusive Disease and Iliac Artery Occlusion, run by Clinical Centre of Serbia at 2 sites in Serbia.
Trial summary
This study compares early and long-term results of the endovascular treatment among patients with different types of aorto-iliac occlusions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aorto-Iliac Occlusive Disease, Iliac Artery Occlusion, Iliac Artery Disease
- What is being tested?
- Stenting of the Common and/or External Iliac Arteries
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesSerbia
- Study dates
- 1 Jan 2013to 1 Sep 2018
- 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 treated with endovascular stent due to aorto-iliac occlusions
Who may be able to join
- Patient has aorto-iliac occlusions type B, C \& D according to TASC-II classification
- Patient suffers from severe claudication (Rutherford 3) or critical limb ischemia (Rutherford 4 and 5)
- Patients fulfilling criteria for endovascular treatment of aorto-iliac occlusion according to criteria of the participating centres.
Who cannot join
- Patients with associated abdominal or iliac aneurysm, restenotic lesions, acute thrombi or dissections,
- Patients who experienced an initial technical failure
Trial locations and contacts
2 sites in 1 country.
Serbia2 sites
Clinical Center of Serbia
Belgrade, 11000
Institute for Cardiovascular Diseases Dedinje
Belgrade, 11000
About this study
Official title: Endovascular Treatment of Different Types of Aorto-iliac Occlusions
This study compares early and long-term results of the endovascular treatment among patients with different types of aorto-iliac occlusions.
Read the detailed description
Endovascular treatment has been increasingly applied as a therapeutic option for aorto-iliac occlusive disease during the last decade, becoming the first-line treatment for many of the Trans-Atlantic Inter-Society Consensus document II (TASC II) categories. TASC II document in 2007 stated endovascular treatment as the method of choice up to type B occlusions and surgery for low-risk patients with type C and D occlusions, emphasizing that the patient's comorbidities as well as the operator's long-term success rates should be included in the decision-making process.
Revision of TASC II document in 2015 is suggesting that the preferred revascularization method should be based on each vascular center's competence and experience with the anatomic complexity, considering patient comorbidity and overall prognosis, supporting the endovascular-first approach in all 4 different kinds of lesions in highly experienced centers.
These changes over time are based on expert opinions derived from smaller studies from high volume centers, and that they reflect both the widespread gain of endovascular experience and technical developments over the last 2 decades, leading to a rising number of centers providing an endovascular-first approach even in complex TASC C and D occlusions.
Rationale for offering endovascular-first option to patient with complex lesion would be low risk of complication and long-term patency.
Our intention is to compare early and long-term results of the endovascular treatment among patients with different types of aorto-iliac occlusions in two Serbian vascular centres.
- Being tested
- Stenting of the Common and/or External Iliac Arteries
- Keywords
- endovascular, stent, aorto-iliac, occlusions, iliac
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stenting of the Common and/or External Iliac ArteriesDevice
Also called Percutaneous Transluminal Angioplasty, stent implantation
Stenting of the Common and/or External Iliac Arteries was performed in the angiographic suite. Under local anesthesia, arterial access was obtained through standard percutaneous puncture of the common femoral artery, brachial approach, or simultaneous brachial and femoral approach.
Iliac lesion crossing was achieved through intraluminal or subintimal manner depending on the behavior of the lesion intraoperatively.
Predilatation of the occlusion before stent deployment was performed at the discretion of the operator.
Balloon-expandable stents were used for proximal, ostial lesions, whereas self-expanding stents were deployed in all other lesions.
Both stents were used in long lesions involving heavily calcified common iliac arteries.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular occlusions group | Group of patients with aorto-iliac occlusive disease (TASC B, C, D) in whom stenting of the Common and/or External Iliac Arteries were performed Receives: Device: Stenting of the Common and/or External Iliac Arteries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary artery/stent patency rate
Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation.
Measured: 60 Months
Secondary outcomes (4)
Primary assisted artery/stent patency rate
Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (>70%) at any time post-procedure.
Measured: 60 months
Secondary patency artery/stent rate
Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at any time post-procedure
Measured: 60 months
Clinical success
During the follow-up period, the improvement of Rutherford classification 1 grade or more than 1 grade.
Measured: 60 months
Number of participants with periprocedural complications: hematoma, bleeding, pseudoaneurysm, renal failure, myocardial infarction, stroke, mortality, thrombosis of the treated segment
Identification of serious adverse events requiring correction of therapy or surgery. Will be used physiological parameter and questionnaire.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start1 Jan 2013
- Primary completion1 Nov 2017
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aorto-Iliac Occlusive 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Centre of Serbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimir Cvetic, Clinical Centre of Serbia
- Investigators
- Dragan Z Sagic, Prof, Principal investigator, Institute for Cardiovascular Diseases Dedinje
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824730
- Sponsor's protocol ID
- CCSerbia Vasc
- Status last verified
- Jan 2019
- First submitted
- 25 Jan 2019
- Last updated
- 31 Jan 2019
- 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 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Treatment of Different Types of Aorto-iliac Occlusions
- ClinicalTrials.gov ID
- NCT03824730
- Acronym / sponsor ID
- CCSerbia Vasc
- Keywords
- endovascular, stent, aorto-iliac, occlusions, iliac
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Clinical Centre of SerbiaUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 31 Jan 2019 (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 study compares early and long-term results of the endovascular treatment among patients with different types of aorto-iliac occlusions.
Detailed description
Endovascular treatment has been increasingly applied as a therapeutic option for aorto-iliac occlusive disease during the last decade, becoming the first-line treatment for many of the Trans-Atlantic Inter-Society Consensus document II (TASC II) categories. TASC II document in 2007 stated endovascular treatment as the method of choice up to type B occlusions and surgery for low-risk patients with type C and D occlusions, emphasizing that the patient's comorbidities as well as the operator's long-term success rates should be included in the decision-making process.
Revision of TASC II document in 2015 is suggesting that the preferred revascularization method should be based on each vascular center's competence and experience with the anatomic complexity, considering patient comorbidity and overall prognosis, supporting the endovascular-first approach in all 4 different kinds of lesions in highly experienced centers.
These changes over time are based on expert opinions derived from smaller studies from high volume centers, and that they reflect both the widespread gain of endovascular experience and technical developments over the last 2 decades, leading to a rising number of centers providing an endovascular-first approach even in complex TASC C and D occlusions.
Rationale for offering endovascular-first option to patient with complex lesion would be low risk of complication and long-term patency.
Our intention is to compare early and long-term results of the endovascular treatment among patients with different types of aorto-iliac occlusions in two Serbian vascular centres.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular occlusions group | – | Device: Stenting of the Common and/or External Iliac ArteriesGroup of patients with aorto-iliac occlusive disease (TASC B, C, D) in whom stenting of the Common and/or External Iliac Arteries were performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with endovascular stent due to aorto-iliac occlusions
Key inclusion criteria (3 listed)
- Patient has aorto-iliac occlusions type B, C \& D according to TASC-II classification
- Patient suffers from severe claudication (Rutherford 3) or critical limb ischemia (Rutherford 4 and 5)
- Patients fulfilling criteria for endovascular treatment of aorto-iliac occlusion according to criteria of the participating centres.
Key exclusion criteria (2 listed)
- Patients with associated abdominal or iliac aneurysm, restenotic lesions, acute thrombi or dissections,
- Patients who experienced an initial technical failure
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 |
|---|---|---|
| Stenting of the Common and/or External Iliac ArteriesAlso: Percutaneous Transluminal Angioplasty, stent implantationStenting of the Common and/or External Iliac Arteries was performed in the angiographic suite. Under local anesthesia, arterial access was obtained through standard percutaneous puncture of the common femoral artery, brachial approach, or simultaneous brachial and femoral approach. Iliac lesion crossing was achieved through intraluminal or subintimal manner depending on the behavior of the lesion intraoperatively. Predilatation of the occlusion before stent deployment was performed at the discretion of the operator. Balloon-expandable stents were used for proximal, ostial lesions, whereas self-expanding stents were deployed in all other lesions. Both stents were used in long lesions involving heavily calcified common iliac arteries. | Device | Endovascular occlusions group |
Primary outcome
Primary artery/stent patency rate
Time frame: 60 Months
Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation.
4 secondary outcomes
Primary assisted artery/stent patency rate
Time frame: 60 months
Secondary patency artery/stent rate
Time frame: 60 months
Clinical success
Time frame: 60 months
Number of participants with periprocedural complications: hematoma, bleeding, pseudoaneurysm, renal failure, myocardial infarction, stroke, mortality, thrombosis of the treated segment
Time frame: 1 month
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 31 Jan 2019.
- 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.
Dragan Z Sagic, Prof principal investigator
Institute for Cardiovascular Diseases Dedinje
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aorto-Iliac Occlusive Disease and Iliac Artery Occlusion, run by Clinical Centre of Serbia at 2 sites in Serbia.
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 3 inclusion and 2 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 31 Jan 2019. 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 Serbia. 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 artery/stent patency rate (time frame: 60 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 31 Jan 2019.