Stable AnginaPhase 4COMPACT-ISRNCT01204320
A COMparison Between PAClitaxel-coated Balloon and pacliTaxel-eluting Stent in the Treatment of In-Stent Restenosis (COMPACT-ISR)
A Phase 4 study testing Paclitaxel-coated Balloon and Paclitaxel-eluting Stent in people with Stable Angina and Unstable Angina, run by Ospedale San Donato at 1 site in Italy.
Trial summary
This is a multicentric randomized comparison between paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in patients with stable or unstable angina with the evaluation of restenosis by Quantitative Coronary Analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina, Unstable Angina
- What is being tested?
- Paclitaxel-coated Balloon and Paclitaxel-eluting Stent
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2008to Jan 2010
- 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
- informed consent
- >18y
- Stable Angina or Unstable Angina
- Single restenotic lesion in a previously stented coronary artery
Who cannot join
- Acute Myocardial Infarction within 72h
- Serum Creatinine>2.0 mg/dL
- Contraindications to ASA, Heparin, Clopidogrel, Ticlopidine, Abciximab, Tirofiban, Paclitaxel
- Contraindications to contrast media
- Life expectancy < 2y
- Target Lesion length > 30mm
Show all 10Show fewer
- Target Lesion diameter <= 2.5 mm
- Target stenosis < 70%
- Massive Calcifications in the target segment
- Evidence of intra-coronary thrombus
Trial locations and contacts
1 site in 1 country.
About this study
This is a multicentric randomized comparison between paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in patients with stable or unstable angina with the evaluation of restenosis by Quantitative Coronary Analysis.
Read the detailed description
The purpose of this study is to determine the late luminal loss by Quantitative Coronary Analysis at 6 month-follow up after paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in the treatment of in-stent restenosis.
- Conditions
- Stable Angina, Unstable Angina
- Being tested
- Paclitaxel-coated Balloon, Paclitaxel-eluting Stent
- Keywords
- Restenosis, POBA, Stenting, Paclitaxel
- Medical subject headings
- Angina, Stable, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel-coated BalloonProcedure or surgery
Also called Orbus
POBA
Paclitaxel-eluting StentDevice
Also called Taxus
Stenting
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel-coated Balloon | Experimental | Paclitaxel-coated Balloon Angioplasty Receives: Procedure: Paclitaxel-coated Balloon |
| Paclitaxel-eluting Stent | Active comparator | Paclitaxel-eluting Stent Implantation Receives: Device: Paclitaxel-eluting Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late Luminal Loss defined as the difference between the minimal luminal diameter after stenting and at follow-up by Quantitative Coronary Analysis
Measured: 6 months
Secondary outcomes (3)
Binary restenosis defined as >50% diameter stenosis by QCA
Measured: 6 months
Major Adverse Cardiac Events
Measured: 6, 12 months
Target Lesion Revascularization
Measured: 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startJan 2008
- Primary completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale San Donato
- Sponsor type
- University, hospital or other
- Investigators
- Leonardo Bolognese, MD, Study chair, Cardiovascular Department - San Donato Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204320
- Sponsor's protocol ID
- Arezzo003
- Acronym
- COMPACT-ISR
- Status last verified
- Oct 2009
- First submitted
- 16 Sep 2010
- Last updated
- 17 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A COMparison Between PAClitaxel-coated Balloon and pacliTaxel-eluting Stent in the Treatment of In-Stent Restenosis (COMPACT-ISR)
- ClinicalTrials.gov ID
- NCT01204320
- Acronym / sponsor ID
- COMPACT-ISR / Arezzo003
- Conditions
- Stable Angina, Unstable Angina
- Keywords
- Restenosis, POBA, Stenting, Paclitaxel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Ospedale San DonatoUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2010 (estimated)
- First posted
- 17 Sep 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.
This is a multicentric randomized comparison between paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in patients with stable or unstable angina with the evaluation of restenosis by Quantitative Coronary Analysis.
Detailed description
The purpose of this study is to determine the late luminal loss by Quantitative Coronary Analysis at 6 month-follow up after paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in the treatment of in-stent restenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel-coated Balloon | Experimental | Procedure: Paclitaxel-coated BalloonPaclitaxel-coated Balloon Angioplasty |
| Paclitaxel-eluting Stent | Active comparator | Device: Paclitaxel-eluting StentPaclitaxel-eluting Stent Implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- informed consent
- >18y
- Stable Angina or Unstable Angina
- Single restenotic lesion in a previously stented coronary artery
Key exclusion criteria (10 listed)
- Acute Myocardial Infarction within 72h
- Serum Creatinine>2.0 mg/dL
- Contraindications to ASA, Heparin, Clopidogrel, Ticlopidine, Abciximab, Tirofiban, Paclitaxel
- Contraindications to contrast media
- Life expectancy < 2y
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 |
|---|---|---|
| Paclitaxel-coated BalloonAlso: OrbusPOBA | Procedure or surgery | Paclitaxel-coated Balloon |
| Paclitaxel-eluting StentAlso: TaxusStenting | Device | Paclitaxel-eluting Stent |
Primary outcome
Late Luminal Loss defined as the difference between the minimal luminal diameter after stenting and at follow-up by Quantitative Coronary Analysis
Time frame: 6 months
3 secondary outcomes
Binary restenosis defined as >50% diameter stenosis by QCA
Time frame: 6 months
Major Adverse Cardiac Events
Time frame: 6, 12 months
Target Lesion Revascularization
Time frame: 6, 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2010.
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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.
Leonardo Bolognese, MD study chair
Cardiovascular Department - San Donato Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paclitaxel-coated Balloon and Paclitaxel-eluting Stent in people with Stable Angina and Unstable Angina, run by Ospedale San Donato at 1 site in Italy.
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 10 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: stopped early, as of the sponsor's last update on 17 Sep 2010. 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 Italy. 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 was stopped early. 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?
Late Luminal Loss defined as the difference between the minimal luminal diameter after stenting and at follow-up by Quantitative Coronary Analysis (time frame: 6 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 17 Sep 2010.