Arterial Occlusive DiseasesPhase 2/3NCT00156611
Rio Trial - ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients With Peripheral Arterial Disease
A Phase 2/3 study testing Balloon Angioplasty and ReoPro in people with Arterial Occlusive Diseases, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The Rio Study is a randomized, double blinded German- Swiss- Austria multi-centre trial on the efficacy and safety of ReoPro together with interventional recanalization of TASC D lesions in the SFA and popliteal artery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Arterial Occlusive Diseases
- What is being tested?
- Balloon Angioplasty and ReoPro
- Type of treatment
- Surgery or procedure
- How many people
- 420 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2002to Dec 2009
- Phase
- Phase 2/3
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a history of peripheral artery disease with superficial femoral or popliteal artery occlusion, which mandates PTA or stent administration as first treatment modality. The history of peripheral artery occlusion has to be at least 6 weeks, and the target vessel occlusion has to be more than 5 centimeters in length.
- Age between 18 and 90 years
Who cannot join
- Acute limb ischemia
- Subacute ischemia with requires thrombolysis as first treatment modality
- Active bleeding or known bleeding diathesis
- Known severe hepatic or renal disorder (liver cirrhosis, stage B, C or serum creatinine > 2.5 mg%)
- Hyperthyreosis
- Diabetes mellitus treated with metformin
Show all 23Show fewer
- Known heparin induced thrombocytopenia (HIT, type 2)
- Female sex with childbearing potential
- Major surgery or trauma in past 6 weeks
- History of stroke within the previous 2 years, or any stroke with a residual neurological deficit, or other CNS abnormality (e.g., intracranial neoplasm, arteriovenous malformation, or aneurysm)
- Gastrointestinal or genitourinary bleeding of clinical significance within the previous 6 weeks
- Administration of oral anticoagulants within the previous 7 days unless prothrombin time is < 1.2 times control (or international normalized ratio [INR] <1.4), or ongoing treatment with oral anticoagulants
- History of bleeding diathesis of platelet count < 100,000/mm3
- Arteriovenous malformations or aneurysms
- Severe uncontrolled hypertension (treated sys. BP > 200 mm Hg, diast. BP > 100 mm Hg)
- Hypertensive or diabetic retinopathy
- Vasculitis
- Known autoimmune disorders
- Patient with aspirin intolerance
- Contraindication or known allergic reactions to abciximab or murine proteins
- Co-existent condition associated with a limited life expectancy (e.g., advanced cancer, end-stage congestive heart failure)
- Participation in another clinical research study involving the evaluation of another investigational drug or device within 7 days prior to enrollment
- Patient who has previously received a GP IIb/IIIa antagonist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients With Peripheral Arterial Disease - A Randomized Prospective Trial (RIO-Trial)
The Rio Study is a randomized, double blinded German- Swiss- Austria multi-centre trial on the efficacy and safety of ReoPro together with interventional recanalization of TASC D lesions in the SFA and popliteal artery.
Read the detailed description
Purpose: The RIO trial is designed to test the efficacy of GP IIb/IIIa blockade on subacute reocclusions in patients with interventional recanalization of chronic occlusions in the superficial femoral and popliteal artery.
Methods: A total of 420 patients will be randomly assigned to ReoPro or placebo. Patients will be eligible for randomisation with occlusions longer than 5 cm. Doppler ultrasound follow-up will be at 30 days, and after 6, and 12 months.
- Conditions
- Arterial Occlusive Diseases
- Being tested
- Balloon Angioplasty, ReoPro
- Keywords
- peripheral vascular disease, intervention, restenosis, Age above 18 years
- Medical subject headings
- Arterial Occlusive Diseases, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon AngioplastyProcedure or surgery
ReoProDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of subacute occlusions within 30 days
Secondary outcomes (6)
Prevention of restenosis up to 3 years
Prevention of target lesion revascularization
Improvement of the clinical status
Change of ABI
Hospital days
all secondary outcomes at 30 days, 6 months, one year, and 3 years (telephone contact after 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2002
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Occlusive DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 420 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Investigators
- Gunnar Tepe, MD, Principal investigator, University Hospital of TuebingenIris Baumgartner, MD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156611
- Sponsor's protocol ID
- R-1
- Status last verified
- Sep 2006
- First submitted
- 7 Sep 2005
- Last updated
- 12 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients With Peripheral Arterial Disease - A Randomized Prospective Trial (RIO-Trial)
- ClinicalTrials.gov ID
- NCT00156611
- Acronym / sponsor ID
- R-1
- Conditions
- Arterial Occlusive Diseases
- Keywords
- peripheral vascular disease, intervention, restenosis, Age above 18 years
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- Jan 2002
- Study completion
- Dec 2009
- First posted
- 12 Sep 2005 (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.
The Rio Study is a randomized, double blinded German- Swiss- Austria multi-centre trial on the efficacy and safety of ReoPro together with interventional recanalization of TASC D lesions in the SFA and popliteal artery.
Detailed description
Purpose: The RIO trial is designed to test the efficacy of GP IIb/IIIa blockade on subacute reocclusions in patients with interventional recanalization of chronic occlusions in the superficial femoral and popliteal artery.
Methods: A total of 420 patients will be randomly assigned to ReoPro or placebo. Patients will be eligible for randomisation with occlusions longer than 5 cm. Doppler ultrasound follow-up will be at 30 days, and after 6, and 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a history of peripheral artery disease with superficial femoral or popliteal artery occlusion, which mandates PTA or stent administration as first treatment modality. The history of peripheral artery occlusion has to be at least 6 weeks, and the target vessel occlusion has to be more than 5 centimeters in length.
- Age between 18 and 90 years
Key exclusion criteria (23 listed)
- Acute limb ischemia
- Subacute ischemia with requires thrombolysis as first treatment modality
- Active bleeding or known bleeding diathesis
- Known severe hepatic or renal disorder (liver cirrhosis, stage B, C or serum creatinine > 2.5 mg%)
- Hyperthyreosis
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 |
|---|---|---|
| Balloon Angioplasty | Procedure or surgery | – |
| ReoPro | Drug | – |
Primary outcome
Prevention of subacute occlusions within 30 days
6 secondary outcomes
Prevention of restenosis up to 3 years
Prevention of target lesion revascularization
Improvement of the clinical status
Change of ABI
Hospital days
all secondary outcomes at 30 days, 6 months, one year, and 3 years (telephone contact after 3 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2006.
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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.
Gunnar Tepe, MD principal investigator
University Hospital of Tuebingen
Iris Baumgartner, MD principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Balloon Angioplasty and ReoPro in people with Arterial Occlusive Diseases, run by University Hospital Tuebingen at 1 site in Germany.
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 2 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: status not confirmed, as of the sponsor's last update on 12 Sep 2006. 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 Germany. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Prevention of subacute occlusions within 30 days. 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 12 Sep 2006.