RestenosisPhase 4ISAR-DESIRE 4NCT01632371

Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4

A Phase 4 study testing Paclitaxel Eluting Balloon + Scoring Balloon and Paclitaxel Eluting Balloon in people with Restenosis and Stable Angina Pectoris, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to determine whether scoring balloon (SCB) plus paclitaxel-coated balloon (PCB) is superior to PCB alone for the treatment of restenosis within "limus"-eluting stents (LES) Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Restenosis, Stable Angina Pectoris, Acute Coronary Syndrome
What is being tested?: Paclitaxel Eluting Balloon + Scoring Balloon and Paclitaxel Eluting Balloon
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 252 participants
Where: 2 sitesGermany
Study dates: Jun 2012to Nov 2016
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 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% restenosis after prior implantation of LES in native coronary vessels.
Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
In women with childbearing potential a negative pregnancy test is mandatory.

Who cannot join

Age < 18 years
Cardiogenic shock
Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min)
Contraindications to antiplatelet therapy, paclitaxel, stainless steel, cobalt, chrome

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Therapy including Lovastatin, Ciclosporin, Terfenadine, Midazolam, or Ondansetron
Pregnancy (present, suspected or planned) or positive pregnancy test.
Previous enrollment in this trial.
Patient's inability to fully comply with the study protocol.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

Deutsches Herzzentrum Muenchen
Munich, Bavaria, 80636
1. Med. Klinik am Klinikum rechts der Isar der TU Muenchen
Munich, Bavaria, 81675

Other trials in Germany

About this study

Official title: ISAR-DESIRE 4: Randomized Trial Of Scoring Balloon in Patients With Restenosis in "Limus"-Eluting Coronary Stents Undergoing Angioplasty With Paclitaxel-Coated Balloon

Read the detailed description

The optimal treatment of in-BMS-restenosis seems to be implantation of a DES which is supported by a large body of evidence. Nevertheless, several recent published studies have shown a substantial reduction in late lumen loss and angiographic restenosis using paclitaxel-coated balloons (PCB) for restenotic lesions. Given the increased world-wide use of DES and the use of DES in increasingly complex coronary disease patterns, the number of patients presenting with restenosis after DES implantation will further increase in the coming decade.

Data regarding the optimal treatment of in-DES-restenosis are very limited: Implanting a new DES for in-DES-restenosis has been reported to associate with repeat restenosis rates as high as 20%. In addition, an increased risk of stent thrombosis has been associated with complex stenting and with additional DES implantation. Thus, for lesions which develop restenosis after LES implantation, the optimal treatment strategy remains unknown.

Few results on small sample-size populations have been reported in patients treated with scoring or cutting balloon (SCB) technology for treatment of BMS restenosis as compared to plain balloon angioplasty. Moreover, the efficacy of SCB angioplasty in DES restenosis has not been adequately addressed. Furthermore, the potential additive benefit of SCB angioplasty in patients undergoing PCB therapy remains to be elucidated. The hypothesis behind this concept is that the application of SCB prior to deployment of PCB may increase the bioavailability of paclitaxel within the restenotic tissue, and therefore may increase the efficacy of PCB. There are numerous preclinical studies to support this hypothesis, which show that lesion preparation is an important pre-requisite for the effectiveness of PCB.

Conditions: Restenosis, Stable Angina Pectoris, Acute Coronary Syndrome
Being tested: Paclitaxel Eluting Balloon + Scoring Balloon, Paclitaxel Eluting Balloon
Keywords: In-stent Restenosis, Drug Eluting Stent, Paclitaxel Coated Balloon, Scoring Balloon, Cutting Balloon, Angiographic follow-up, Optical coherence tomography (OCT)
Medical subject headings: Angina, Stable, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Paclitaxel Eluting Balloon + Scoring BalloonDevice
Scoring/cutting balloon lesion predilation; paclitaxel eluting balloon therapy
Paclitaxel Eluting BalloonDevice
Standard balloon lesion predilation; paclitaxel-eluting balloon therapy

Study groups in NCT01632371
Study group	Role	What they receive
Paclitaxel Eluting Balloon + Scoring Balloon	Experimental	Dilatation of the lesion with an Paclitaxel Eluting Balloon before the utilization of a Scoring Balloon Receives: Device: Paclitaxel Eluting Balloon + Scoring Balloon
Paclitaxel Eluting Balloon	Active comparator	Paclitaxel Eluting Balloon Receives: Device: Paclitaxel Eluting Balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

In-segment percent diameter stenosis
In-segment percent diameter stenosis (%DS) at 6-8 month follow-up angiography
Measured: 6-8 months

Secondary outcomes (6)

In-stent late lumen loss
The difference between minimal lumen diameter post-procedure and minimal lumen diameter at follow-up angiography
Measured: 6-8 months
In-segment binary angiographic restenosis
diameter stenosis ≥50% in the in-segment area (including the interventional area as well as 5 mm margins proximal and distal) at follow-up angiography
Measured: 6-8 month
Death or myocardial infarction
Combined incidence of death or myocardial infarction at one and two year
Measured: 1 and 2 years
Target lesion revascularization
Need for target lesion revascularization (TLR), defined as any revascularization procedure involving the target lesion due to luminal re-narrowing in the presence of symptoms or objective signs of ischemia at one and two year follow-up
Measured: 1 and 2 years
Target lesion thrombosis
Incidence of target lesion thrombosis at one and two years
Measured: 1 and 2 years
OCT tissue characterization
Tissue characterization following application of SCB and PCB using OCT at 6 -8 months follow up
Measured: 6-8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Nov 2016

First posted2 Jul 2012 (estimated)
Study startJun 2012
Primary completionAug 2015
Study completionNov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 252 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01632371
Sponsor's protocol ID: GE IDE NO. S00112
Other IDs: CIV-12-05-006401
Acronym: ISAR-DESIRE 4
Status last verified: Nov 2016
First submitted: 26 Jun 2012
Last updated: 21 Nov 2016
Results posted: No
Data monitoring committee: No

Publications

Kufner S, Joner M, Schneider S, Tolg R, Zrenner B, Repp J, Starkmann A, Xhepa E, Ibrahim T, Cassese S, Fusaro M, Ott I, Hengstenberg C, Schunkert H, Abdel-Wahab M, Laugwitz KL, Kastrati A, Byrne RA; ISAR-DESIRE 4 Investigators. Neointimal Modification With Scoring Balloon and Efficacy of Drug-Coated Balloon Therapy in Patients With Restenosis in Drug-Eluting Coronary Stents: A Randomized Controlled Trial. JACC Cardiovasc Interv. 2017 Jul 10;10(13):1332-1340. doi: 10.1016/j.jcin.2017.04.024.
PubMed 28683939

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
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A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
In-Stent Restenosis
Active, not recruitingPhase 3
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort
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All Restenosis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ISAR-DESIRE 4: Randomized Trial Of Scoring Balloon in Patients With Restenosis in "Limus"-Eluting Coronary Stents Undergoing Angioplasty With Paclitaxel-Coated Balloon
ClinicalTrials.gov ID: NCT01632371
Acronym / sponsor ID: ISAR-DESIRE 4 / GE IDE NO. S00112
Conditions: Restenosis, Stable Angina Pectoris, Acute Coronary Syndrome
Keywords: In-stent Restenosis, Drug Eluting Stent, Paclitaxel Coated Balloon, Scoring Balloon, Cutting Balloon, Angiographic follow-up, Optical coherence tomography (OCT)
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 252 participants (actual)
Lead sponsor: Deutsches Herzzentrum MuenchenUniversity, hospital or other
Collaborators: Biotronik AG
Study start: Jun 2012
Primary completion: Aug 2015 (actual)
Study completion: Nov 2016 (actual)
First posted: 2 Jul 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Paclitaxel Eluting Balloon + Scoring Balloon	Experimental	Device: Paclitaxel Eluting Balloon + Scoring BalloonDilatation of the lesion with an Paclitaxel Eluting Balloon before the utilization of a Scoring Balloon
Paclitaxel Eluting Balloon	Active comparator	Device: Paclitaxel Eluting BalloonPaclitaxel Eluting Balloon

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% restenosis after prior implantation of LES in native coronary vessels.
Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
In women with childbearing potential a negative pregnancy test is mandatory.

Key exclusion criteria (10 listed)

Age < 18 years
Cardiogenic shock
Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min)

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 Eluting Balloon + Scoring BalloonScoring/cutting balloon lesion predilation; paclitaxel eluting balloon therapy	Device	Paclitaxel Eluting Balloon + Scoring Balloon
Paclitaxel Eluting BalloonStandard balloon lesion predilation; paclitaxel-eluting balloon therapy	Device	Paclitaxel Eluting Balloon

Primary outcome

In-segment percent diameter stenosis
Time frame: 6-8 months
In-segment percent diameter stenosis (%DS) at 6-8 month follow-up angiography

6 secondary outcomes

In-stent late lumen loss
Time frame: 6-8 months
In-segment binary angiographic restenosis
Time frame: 6-8 month
Death or myocardial infarction
Time frame: 1 and 2 years
Target lesion revascularization
Time frame: 1 and 2 years
Target lesion thrombosis
Time frame: 1 and 2 years
OCT tissue characterization
Time frame: 6-8 months

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 21 Nov 2016.
Derived from this study: PubMed 28683939Kufner S, Joner M, Schneider S, Tolg R, Zrenner B, Repp J, Starkmann A, Xhepa E, Ibrahim T, Cassese S, Fusaro M, Ott I, Hengstenberg C, Schunkert H, Abdel-Wahab M, Laugwitz KL, Kastrati A, Byrne RA; ISAR-DESIRE 4 Investigators. Neointimal Modification With Scoring Balloon and Efficacy of Drug-Coated Balloon Therapy in Patients With Restenosis in Drug-Eluting Coronary Stents: A Randomized Controlled Trial. JACC Cardiovasc Interv. 2017 Jul 10;10(13):1332-1340. doi: 10.1016/j.jcin.2017.04.024.

Related trials for Restenosis

Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
Not yet recruitingObservational study
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal In-Stent Restenosis (ISR)
Active, not recruitingPhase 3
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
In-Stent Restenosis
Active, not recruitingPhase 3
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort
In-Stent Restenosis
Not yet recruitingObservational study
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
Chronic Venous Disease, Chronic Venous Insufficiency, CVI

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.

Adnan Kastrati, MD study chair

Deutsches Herzzentrum Munich

Robert Byrne, MB PhD principal investigator

Deutsches Herzzentrum Munich

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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: finished, as of the sponsor's last update on 21 Nov 2016. 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 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 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?

In-segment percent diameter stenosis (time frame: 6-8 months). 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 NCT01632371, which also lists 1 linked publication.

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 21 Nov 2016.