Instent RestenosisPhase 4NCT01066832
The Valentines Trial
A Phase 4 study testing Paclitaxel in people with Instent Restenosis, run by Eurocor GmbH at 3 sites in 3 countries.
Trial summary
The primary objective of this multi-center, international, short term registry is to assess clinical success and efficacy of the paclitaxel eluting balloon treatment for in-stent restenosis at 6-9 months follow up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Instent Restenosis
- What is being tested?
- Paclitaxel
- How many people
- 276 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Feb 2010to Mar 2011
- Phase
- Phase 4
- 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
- Patients, male or female, > 18 years of age;
- Patients who present with in-stent restenosis of a previously placed stent documented by coronary angiogram for which re-PCI is planned;
- The patient has stable or unstable angina, and/or clinical evidence of ischemia (ECG, exercise test, etc.);
- The target lesion is in a native vessel;
- Up to two lesions per patient;
- Target lesion(s) stenosis is > 50%.
Who cannot join
- The patient has had an acute myocardial infarction within the last 48 hours;
- The patient has a co-morbid illness (i.e. any illness likely to limit his/her life expectancy to <12 months);
- Lesion(s) requiring additional stenting either bare metal or drug eluting (non, bail-out indications);
- The patient has had previous therapeutic radiation to the target vessel;
- The patient is unable the take dual antiplatelet therapy for at least 6 months;
- Patients with three or more lesions with in-stent restenosis requiring angioplasty.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
The primary objective of this multi-center, international, short term registry is to assess clinical success and efficacy of the paclitaxel eluting balloon treatment for in-stent restenosis at 6-9 months follow up. Clinical success defined as freedom from major adverse cardiac events (MACE: death, myocardial infarction [MI], target lesion revascularization [TLR]) and target vessel revascularization [TVR]) and stent thrombosis, both early and late occurrences will be assessed.
In addition, a cohort of the registry will undergo angiographic follow up at 6-9 months to assess in-stent and in-segment late loss and binary restenosis subsequent to paclitaxel eluting balloon treatment for in-stent restenosis.
A prioi analysis will be comparison of the safety and efficacy of patients presenting with drug-eluting stent in-stent restenosis to bare metal stent in-stent restenosis.
- Conditions
- Instent Restenosis
- Being tested
- Paclitaxel
- Keywords
- Drug-eluting balloon, Paclitaxel, DIOR, short term registry, Valentines Trial, Drug-eluting balloon treatment of in-stent restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Paclitaxel-coated balloon (3 µg/mm2)
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success at 6-9 month defined as freedom from MACE, death, MI,TLR and stent thrombosis
Measured: 6-9 month
Secondary outcomes (1)
In-stent and in-segment late loss and binary restenosis
Measured: 6-9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Instent RestenosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurocor GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pieter Stella, MD, PhD, Principal investigator, UMC Utrecht, Utrecht, NetherlandsSigmund Silber, Prof., Principal investigator, Heart Center Munich at the Isar, Munich, GermanyGiuseppe Sangiorgi, MD, Principal investigator, Policlinico Modena, Modena, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066832
- Sponsor's protocol ID
- Eur-001
- Status last verified
- Feb 2010
- First submitted
- 9 Feb 2010
- Last updated
- 17 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Valentines Trial
- ClinicalTrials.gov ID
- NCT01066832
- Acronym / sponsor ID
- Eur-001
- Conditions
- Instent Restenosis
- Keywords
- Drug-eluting balloon, Paclitaxel, DIOR, short term registry, Valentines Trial, Drug-eluting balloon treatment of in-stent restenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Eurocor GmbHIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Feb 2010 (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 primary objective of this multi-center, international, short term registry is to assess clinical success and efficacy of the paclitaxel eluting balloon treatment for in-stent restenosis at 6-9 months follow up. Clinical success defined as freedom from major adverse cardiac events (MACE: death, myocardial infarction [MI], target lesion revascularization [TLR]) and target vessel revascularization [TVR]) and stent thrombosis, both early and late occurrences will be assessed.
In addition, a cohort of the registry will undergo angiographic follow up at 6-9 months to assess in-stent and in-segment late loss and binary restenosis subsequent to paclitaxel eluting balloon treatment for in-stent restenosis.
A prioi analysis will be comparison of the safety and efficacy of patients presenting with drug-eluting stent in-stent restenosis to bare metal stent in-stent restenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients, male or female, > 18 years of age;
- Patients who present with in-stent restenosis of a previously placed stent documented by coronary angiogram for which re-PCI is planned;
- The patient has stable or unstable angina, and/or clinical evidence of ischemia (ECG, exercise test, etc.);
- The target lesion is in a native vessel;
- Up to two lesions per patient;
Key exclusion criteria (6 listed)
- The patient has had an acute myocardial infarction within the last 48 hours;
- The patient has a co-morbid illness (i.e. any illness likely to limit his/her life expectancy to <12 months);
- Lesion(s) requiring additional stenting either bare metal or drug eluting (non, bail-out indications);
- The patient has had previous therapeutic radiation to the target vessel;
- The patient is unable the take dual antiplatelet therapy for at least 6 months;
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 |
|---|---|---|
| PaclitaxelPaclitaxel-coated balloon (3 µg/mm2) | Drug | – |
Primary outcome
Clinical success at 6-9 month defined as freedom from MACE, death, MI,TLR and stent thrombosis
Time frame: 6-9 month
1 secondary outcome
In-stent and in-segment late loss and binary restenosis
Time frame: 6-9 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 17 Jun 2011.
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.
Pieter Stella, MD, PhD principal investigator
UMC Utrecht, Utrecht, Netherlands
Sigmund Silber, Prof. principal investigator
Heart Center Munich at the Isar, Munich, Germany
Giuseppe Sangiorgi, MD principal investigator
Policlinico Modena, Modena, Italy
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paclitaxel in people with Instent Restenosis, run by Eurocor GmbH at 3 sites in 3 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 6 inclusion and 6 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 17 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Italy, Netherlands. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical success at 6-9 month defined as freedom from MACE, death, MI,TLR and stent thrombosis (time frame: 6-9 month). 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 17 Jun 2011.