Coronary Instent RestenosisPhase 3PEPCADNCT01622075
A Safety and Efficacy Study of Paclitaxel-eluting Balloon to Paclitaxel-eluting Stent
A Phase 3 study testing SeQuent® Please and Taxus Liberte in people with Coronary Instent Restenosis, run by B. Braun Medical International Trading Company Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of successful interventional therapy and unblocked blood vessel maintaining in the treatment of coronary in-stent restenosis by paclitaxel -eluting PTCA- balloon catheter (3μg/mm2 balloon surface area) versus paclitaxel-eluting stent Taxus® Liberte, and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Instent Restenosis
- What is being tested?
- SeQuent® Please and Taxus Liberte
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- Mar 2011to Apr 2014
- Phase
- Phase 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Related to patients
- Patients with stable angina, unstable angina, old myocardial infarction or proven asymptomatic ischemia
- Restenosis after the first stent implant
- Patients who can receive any kind of coronary revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting)
- Patient aged 18-80 (including 18 and 80)
- Female patients of childbearing age in the study period shall not be pregnant or protocol to be pregnant, it is suggested that patients shall take sufficient contraception measures till (including) the follow-up visit of month 9
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- Patients who agree to accept the angiography follow-up visits of month 9
- Patients who agree to accept the clinical visits at Day 30, Month 6 and Month 12
- Patients can understand the study objectives psychologically and linguistically and show the sufficient compliance to the study protocol. Patients present acceptance of the risks and benefits described in the informed consent form.
- Related to lesion
- Drug-eluting stent restenosis: Type Mehran I, Type II and Type III; the reference blood vessel diameter is 2.5 mm-4.0 mm, length ≤30mm
- Before surgery, stenosis diameter must be ≥70% or ≥50% and accompanied by ischemia
- The distance between other lesion requires interventional therapy and the target lesion must be >10mm
- In the stent group, up to two paclitaxel drug stents are permitted to be implanted in series
Who cannot join
- Related to patients
- Patients with myocardial infarction within one week
- Patients with severe congestive heart failure or NYHA IV severe heart failure
- Patients with severe valvular heart disease
- Female patients in pregnancy or lactation
- Patients with the life expectancy not exceeding 1 year or the factors causing difficult clinical follow-up visits
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- Patients with hemorrhagic tendency, prohibited to take anticoagulants or antiplatelet drugs
- Patients with stroke within 6 months before the surgery
- Patients taking part in any other clinical tests
- Existing sever renal failure (GFR<30ml/min) or the history, so not meeting the conditions of angiography
- Patients with cardiac transplantation
- Patients not included for other reasons from the investigators
- Related to lesion
- Evidence of extensive thrombus in target blood vessel before the intervention
- Percutaneous coronary intervention for many in-stent restenosis lesions in same artery
- 3-vessel disease that all need to be intervented
- In bifurcation lesions, branch open blood vessel diameter ≥2.5mm
- Percutaneous coronary intervention of venous graft
- Entire shut of Grade TIMI 0 blood flow (Type Mehran IV stenosis)
- Open lesion at left primary and within 2mm
- Related to concomitant therapy
- Patients cannot tolerate aspirin and/or clopidogrel, patients with the history of neutrocytopenia or thrombocytopenia, or patients with severe hypohepatia and prohibited to take clopidogrel
- Patients known allergic to paclitaxel
- Patients with the history of leucopenia (numeration of leukocytes <3x109/L, exceeding 3 days), neutrocytopenia (ANC<1000 neutrocytes/mm3, exceeding 3 days) or thrombocytopenia (<100,000 platelets/mm3
- Patients with the history of peptic ulcer or gastrointestinal hemorrhage in the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Active Controlled Clinical Study to Evaluate the Safety and Efficacy of the Treatment of In-stent Restenosis Lesion by Paclitaxel-eluting PTCA- Balloon Catheter Versus Paclitaxel-eluting Stent
The purpose of this study is to evaluate the efficacy and safety of successful interventional therapy and unblocked blood vessel maintaining in the treatment of coronary in-stent restenosis by paclitaxel -eluting PTCA- balloon catheter (3μg/mm2 balloon surface area) versus paclitaxel-eluting stent Taxus® Liberte, and the reference diameter of coronary artery stenosis is 2.5mm-4.0mm and the length ≤30mm.
- Conditions
- Coronary Instent Restenosis
- Being tested
- SeQuent® Please, Taxus Liberte
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeQuent® PleaseDevice
Also called Paclitaxel Drug-eluting Coronary Artery Balloon Catheter
SeQuent® Please with a length of 10mm,15mm,17mm,20mm and 26mm and diameter of 2.5 mm, 2.75 mm, 3.0mm, 3.5mm and 4.0mm are to be used in the trial
Taxus LiberteDevice
Also called Paclitaxel Drug-eluting Coronary Stent and Conveying System
Taxus Liberte with a length of 8mm,12mm,16mm,20mm and 24mm and diameter of 2.5 mm, 2.75 mm, 3.0mm, 3.5mm and 4.0mm are to be used in the trial
| Study group | Role | What they receive |
|---|---|---|
| SeQuent® Please | Experimental | Paclitaxel Drug-eluting Coronary Artery Balloon Catheter Receives: Device: SeQuent® Please |
| Taxus Liberte | Active comparator | Paclitaxel Drug-eluting Coronary Stent and Conveying System Receives: Device: Taxus Liberte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late lumen loss in segment section at M9
To measure the diameter loss in segment restenosis of the target lesion vessel by using angiography
Measured: One year
Secondary outcomes (2)
Success rate of the interventional therapy
To compare the successful treatment of coronary artery stent restenosis intervention between Paclitaxel release PTCA balloon and Taxus® Liberte, including apparatus success, lesion success and clinical success
Measured: Two year
Outcomes of clinical follow-up visits for drug stent versus drug balloon
- Binary restenosis rate in lesion section at M9
- Cardiovascular clinical composite endpoints related to apparatus at D30, M6, M9, M12 and M24, including cardiac death, target blood vessel myocardial infarction and target lesion vessel revascularization driven by clinical symptoms, briefed as target lesion failure
- Cardiovascular clinical composite endpoints related to patients at D30, M6, M9, M12 and M24, including all-cause death, all myocardial infarction and any vessel revascularization
- Thrombus event rate defined by ARC
Measured: Two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startMar 2011
- Primary completionApr 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Medical International Trading Company Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Runlin Gao, Prof., Principal investigator, Fuwai CVD Hospital of Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622075
- Sponsor's protocol ID
- AE-V-S-1001
- Acronym
- PEPCAD
- Status last verified
- Jul 2015
- First submitted
- 5 Jun 2012
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Xu B, Qian J, Ge J, Wang J, Chen F, Chen J, Wei M, Chen Y, Yang Y, Gao R; PEPCAD China ISR investigators. Two-year results and subgroup analyses of the PEPCAD China in-stent restenosis trial: A prospective, multicenter, randomized trial for the treatment of drug-eluting stent in-stent restenosis. Catheter Cardiovasc Interv. 2016 Mar;87 Suppl 1:624-9. doi: 10.1002/ccd.26401. Epub 2016 Jan 17.
PubMed 26775079Xu B, Gao R, Wang J, Yang Y, Chen S, Liu B, Chen F, Li Z, Han Y, Fu G, Zhao Y, Ge J; PEPCAD China ISR Trial Investigators. A prospective, multicenter, randomized trial of paclitaxel-coated balloon versus paclitaxel-eluting stent for the treatment of drug-eluting stent in-stent restenosis: results from the PEPCAD China ISR trial. JACC Cardiovasc Interv. 2014 Feb;7(2):204-211. doi: 10.1016/j.jcin.2013.08.011.
PubMed 24556098
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Active Controlled Clinical Study to Evaluate the Safety and Efficacy of the Treatment of In-stent Restenosis Lesion by Paclitaxel-eluting PTCA- Balloon Catheter Versus Paclitaxel-eluting Stent
- ClinicalTrials.gov ID
- NCT01622075
- Acronym / sponsor ID
- PEPCAD / AE-V-S-1001
- Conditions
- Coronary Instent Restenosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- B. Braun Medical International Trading Company Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 18 Jun 2012 (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 purpose of this study is to evaluate the efficacy and safety of successful interventional therapy and unblocked blood vessel maintaining in the treatment of coronary in-stent restenosis by paclitaxel -eluting PTCA- balloon catheter (3μg/mm2 balloon surface area) versus paclitaxel-eluting stent Taxus® Liberte, and the reference diameter of coronary artery stenosis is 2.5mm-4.0mm and the length ≤30mm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SeQuent® Please | Experimental | Device: SeQuent® PleasePaclitaxel Drug-eluting Coronary Artery Balloon Catheter |
| Taxus Liberte | Active comparator | Device: Taxus LibertePaclitaxel Drug-eluting Coronary Stent and Conveying System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Related to patients
- Related to lesion
Key exclusion criteria (25 listed)
- Related to patients
- Related to lesion
- Related to concomitant therapy
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 |
|---|---|---|
| SeQuent® PleaseAlso: Paclitaxel Drug-eluting Coronary Artery Balloon CatheterSeQuent® Please with a length of 10mm,15mm,17mm,20mm and 26mm and diameter of 2.5 mm, 2.75 mm, 3.0mm, 3.5mm and 4.0mm are to be used in the trial | Device | SeQuent® Please |
| Taxus LiberteAlso: Paclitaxel Drug-eluting Coronary Stent and Conveying SystemTaxus Liberte with a length of 8mm,12mm,16mm,20mm and 24mm and diameter of 2.5 mm, 2.75 mm, 3.0mm, 3.5mm and 4.0mm are to be used in the trial | Device | Taxus Liberte |
Primary outcome
Late lumen loss in segment section at M9
Time frame: One year
To measure the diameter loss in segment restenosis of the target lesion vessel by using angiography
2 secondary outcomes
Success rate of the interventional therapy
Time frame: Two year
Outcomes of clinical follow-up visits for drug stent versus drug balloon
Time frame: Two year
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 24 Jul 2015.
- Derived from this study: PubMed 26775079Xu B, Qian J, Ge J, Wang J, Chen F, Chen J, Wei M, Chen Y, Yang Y, Gao R; PEPCAD China ISR investigators. Two-year results and subgroup analyses of the PEPCAD China in-stent restenosis trial: A prospective, multicenter, randomized trial for the treatment of drug-eluting stent in-stent restenosis. Catheter Cardiovasc Interv. 2016 Mar;87 Suppl 1:624-9. doi: 10.1002/ccd.26401. Epub 2016 Jan 17.
- Derived from this study: PubMed 24556098Xu B, Gao R, Wang J, Yang Y, Chen S, Liu B, Chen F, Li Z, Han Y, Fu G, Zhao Y, Ge J; PEPCAD China ISR Trial Investigators. A prospective, multicenter, randomized trial of paclitaxel-coated balloon versus paclitaxel-eluting stent for the treatment of drug-eluting stent in-stent restenosis: results from the PEPCAD China ISR trial. JACC Cardiovasc Interv. 2014 Feb;7(2):204-211. doi: 10.1016/j.jcin.2013.08.011.
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.
Runlin Gao, Prof. principal investigator
Fuwai CVD Hospital of Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SeQuent® Please and Taxus Liberte in people with Coronary Instent Restenosis, run by B. Braun Medical International Trading Company Ltd. at 1 site in China.
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 14 inclusion and 25 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 24 Jul 2015. 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 China. 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 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?
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?
Late lumen loss in segment section at M9 (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01622075, which also lists 2 linked publications.
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 24 Jul 2015.