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Coronary Artery DiseaseAGENT-ISRNCT02151812

Comparison of Agent™ and SeQuent® Please Paclitaxel Coated Balloon Catheters in Coronary In-stent Restenosis (AGENT-ISR)

A study testing Agent Paclitaxel-coated balloon and SeQuent® Please Paclitaxel-coated Balloon in people with Coronary Artery Disease and Coronary Restenosis, run by Hemoteq AG at 12 sites in 2 countries.

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 primary objective of this study is determine the safety and performance of the Agent™ Paclitaxel-Coated PTCA Balloon Catheter compared to the SeQuent® Please Paclitaxel-Releasing Coronary Balloon Catheter for the treatment of patients with narrowed previously-stented coronary arteries (in-stent restenosis). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Agent Paclitaxel-coated balloon and SeQuent® Please Paclitaxel-coated Balloon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
12 sitesin 2 countries
Study dates
13 Aug 2014to 28 Oct 2019
Phase
Interventional
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

  • Subject must be at least 18 years of age
  • Subject is willing and able to provide informed consent
  • Subject is eligible for percutaneous coronary intervention
  • Subject is willing to comply with all protocol-required follow-up evaluations
  • Women of child-bearing potential must agree to use a reliable method of contraception
  • In-stent restenosis in a lesion previously treated with either a drug-eluting or bare metal stent, located in a native coronary artery with a reference vessel diameter ≥ 2.0 mm and ≤ 3.5 mm
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  • Target lesion length must be ≤ 28 mm (by visual estimate) and must be covered by only one balloon
  • Target lesion must have visually estimated stenosis ≥ 70% and < 100% in asymptomatic patients
  • Target lesion must have visually estimated stenosis ≥ 50% and < 100% in symptomatic patients
  • Thrombolysis in Myocardial Infarction (TIMI) grade flow in the target lesion must be ≥ 1
  • Target lesion must be successfully pre-dilated.

Who cannot join

  • Patient has life expectancy of less than 24 months
  • Patient with known coronary artery spasm
  • Patient with unprotected left main coronary artery disease
  • Patient has current problems with substance abuse
  • Patient has planned procedure that may cause non-compliance with the protocol or confound data interpretation
  • Patient is participating in another investigational drug or device clinical study that has not reached its primary endpoint
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  • Patient intends to participate in another investigational drug or device clinical study within 12 months after the index procedure
  • Woman who is pregnant or nursing
  • Left ventricular ejection fraction < 25%
  • Patient had PCI or other coronary interventions within the last 30 days
  • Planned PCI or CABG after the index procedure
  • Patient to receive other PCI interventions in the target vessel, such as rotablation, laser atherectomy, cutting balloon, DCB, DES, BMS, bioabsorbable scaffold etc.
  • Patient to receive DCB in non-target coronary vessels
  • Acute MI < 72h
  • Cardiogenic shock
  • Known allergies against Paclitaxel or other components of the used medical devices
  • Known hypersensitivity or contraindication for contrast dye that cannot be adequately pre-medicated
  • Intolerance to antiplatelet drugs, anticoagulants required for the procedure
  • Platelet count < 100k/mm3 or > 500k/mm3
  • Patient with renal failure with a serum creatinine of > 2.5mg/dL who is receiving dialysis or chronic immunosuppressant therapy
  • Target lesion is located within a bifurcation involving a major side branch > 2 mm in diameter
  • Target lesion is located within a saphenous vein graft or an arterial graft
  • Target lesion with TIMI grade flow = 0 (total occlusion)
  • Thrombus present in the target vessel
  • > 50% stenosis of an additional lesion proximal or distal to the target lesion

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

Germany7 sites

  • Kerckhoff-Klinik

    Bad Nauheim, 61231

  • Charité Universitaetsmedizin Berlin

    Berlin, 13353

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

  • University Giessen

    Giessen, 35392

  • Klinikum Am Steinenberg

    Reutlingen, 72764

  • Universitaetsklinikum Rostock

    Rostock, 18057

  • Universitaetsklinikum Ulm

    Ulm, 89081

Other trials in Germany

France5 sites

  • Centre Hospitalier Saint Joseph Saint Luc de Lyon

    Lyon, 69007

  • Clinique du Millénaire, Montpellier

    Montpellier, 34000

  • CHU Montpellier, Hôpital Arnaud de Villeneuve

    Montpellier, 34090

  • CHU de Nantes, Hopital Laennec

    Nantes, 44093

  • Clinique Saint Hilaire, Rouen

    Rouen, 76000

Other trials in France

About this study

Official title: A Prospective Randomized Multicenter Non-inferiority Clinical Study to Determine the Safety and Performance of the Agent™ Paclitaxel-Coated PTCA Balloon Catheter (Hemoteq) Compared to the SeQuent® Please Paclitaxel-Releasing Coronary Balloon Catheter (B.Braun) for the Treatment of Coronary In-Stent Restenosis (AGENT-ISR)

The primary objective of this study is determine the safety and performance of the Agent™ Paclitaxel-Coated PTCA Balloon Catheter compared to the SeQuent® Please Paclitaxel-Releasing Coronary Balloon Catheter for the treatment of patients with narrowed previously-stented coronary arteries (in-stent restenosis).

The performance will be determined at six months post-procedure by quantitative coronary angiography (QCA) to measure Late Lumen Loss (LLL) in the re-opened stented segment. QCA results will be assessed by an independent, blinded angiographic core lab.

Study statistical hypothesis: The loss of in-stent luminal diameter at six months after treatment of the restenosed stent with the Agent™ study device is not larger than the respective LLL after treatment with the SeQuent® Please control devices, i.e. study device is non-inferior to the control device with respect to LLL.

Being tested
Agent Paclitaxel-coated balloon, SeQuent® Please Paclitaxel-coated Balloon
Medical subject headings
Coronary Artery Disease, Coronary Restenosis

What participants receive

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

  • Agent Paclitaxel-coated balloonDevice

    After successful pre-dilatation, the index lesion is dilated with a single drug-coated balloon that completely covers the restenotic lesion.

  • SeQuent® Please Paclitaxel-coated BalloonDevice

    After successful pre-dilatation, the index lesion is dilated with a single drug-coated balloon that completely covers the restenotic lesion.

Study groups in NCT02151812
Study groupRoleWhat they receive
Agent Paclitaxel-coated balloonExperimentaldrug-coated balloon dilatation of the index lesion using a single Agent(TM) balloon that completely covers the restenotic lesion
Receives: Device: Agent Paclitaxel-coated balloon
SeQuent Please Paclitaxel-coated balloonActive comparatordrug-coated balloon dilatation of the index lesion using a single SeQuent(R) Please balloon that completely covers the restenotic lesion
Receives: Device: SeQuent® Please Paclitaxel-coated Balloon

What is being measured

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

  1. in-stent late lumen loss

    In-stent late lumen loss (LLL) of the treated stented segment after PTCA using the Agent(TM) study device in comparison to the LLL after PTCA using the SeQuent(R) Please control device as measured by QCA at six months post-index procedure.

    Measured: six months

Secondary outcomes (55)

  1. technical success rate

    The ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30 percent

    Measured: during index procedure, less 1 hour

  2. clinical procedural success rate

    Technical success with no composite of all death and MI noted within 24 hours of the index procedure.

    Measured: within 24 hours of index procedure

  3. In-stent percent diameter stenosis

    In-stent percent diameter reduction measured within the borders of the stent

    Measured: 6 months post-index procedure

  4. In-segment percent diameter stenosis

    In-segment percent diameter reduction measured in the stented segment plus 5mm on either side.

    Measured: 6 months post-index procedure

  5. In-stent binary restenosis rate

    In-stent binary restenosis is defined as ≥50% luminal narrowing within the borders of the stent observed at follow-up QCA.

    Measured: 6 months post-index procedure

  6. In-segment binary restenosis rate

    In-segment binary restenosis is defined as ≥50% luminal narrowing in the stented segment plus 5mm on either side observed at follow-up QCA.

    Measured: 6 months post-index procedure

  7. In-segment late lumen loss

    In-segment late lumen loss is the in-segment minimal lumen diameter (MLD) post index procedure minus the in-segment MLD at 6 months follow-up as determined by QCA.

    Measured: 6 months post-index procedure

  8. In-stent minimal lumen diameter (MLD)

    In-stent MLD is measured within the borders of the stent.

    Measured: 6 months post-index procedure

  9. In-segment minimal lumen diameter (MLD)

    In-segment MLD is measured in the stented segment plus 5mm on either side.

    Measured: 6 months post-index procedure

  10. Target lesion revascularization (TLR) rate

    TLR rate during index in-hospital stay

    Measured: pre-discharge, estim. <10 days

  11. Target lesion revascularization (TLR) rate

    Measured: 30 days

  12. Target lesion revascularization (TLR) rate

    Measured: six months

  13. Target lesion revascularization (TLR) rate

    Measured: 12 months

  14. Target lesion revascularization (TLR) rate

    Measured: 24 months

  15. Target lesion revascularization (TLR) rate

    Measured: 36 months

  16. Target vessel revascularization (TVR) rate

    TVR rate during index in-hospital stay

    Measured: pre-discharge, estim. <10 days

  17. Target vessel revascularization (TVR) rate

    Measured: 30 days

  18. Target vessel revascularization (TVR) rate

    Measured: six months

  19. Target vessel revascularization (TVR) rate

    Measured: 12 months

  20. Target vessel revascularization (TVR) rate

    Measured: 24 months

  21. Target vessel revascularization (TVR) rate

    Measured: 36 months

  22. Cardiac, non-cardiac and all death rates

    rates during index in-hospital stay

    Measured: pre-discharge, estim. <10 days

  23. Cardiac, non-cardiac and all death rates

    Measured: 30 days

  24. Cardiac, non-cardiac and all death rates

    Measured: six months

  25. Cardiac, non-cardiac and all death rates

    Measured: 12 months

  26. Cardiac, non-cardiac and all death rates

    Measured: 24 months

  27. Cardiac, non-cardiac and all death rates

    Measured: 36 months

  28. Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)

    rates during index in-hospital stay

    Measured: pre-discharge, estim. <10 days

  29. Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)

    Measured: 30 days

  30. Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)

    Measured: six months

  31. Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)

    Measured: 12 months

  32. Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)

    Measured: 24 months

  33. Myocardial infarction rates (by 3rd Universal Definition: all MI, QWMI, NQWMI)

    Measured: 36 months

  34. Stent thrombosis rate (by ARC definition)

    rates during index in-hospital stay

    Measured: pre-discharge, estim. <10 days

  35. Stent thrombosis rate (by ARC definition)

    Measured: 30 days

  36. Stent thrombosis rate (by ARC definition)

    Measured: six months

  37. Stent thrombosis rate (by ARC definition)

    Measured: 12 months

  38. Stent thrombosis rate (by ARC definition)

    Measured: 24 months

  39. Stent thrombosis rate (by ARC definition)

    Measured: 36 months

  40. Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)

    rates during index in-hospital stay

    Measured: pre-discharge, estim. <10 days

  41. Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)

    Measured: 30 days

  42. Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)

    Measured: six months

  43. Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)

    Measured: 12 months

  44. Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)

    Measured: 24 months

  45. Target lesion failure (TLF) rate (composite of cardiac death, MI and TLR)

    Measured: 36 months

  46. Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)

    rates during index in-hospital stay

    Measured: pre-discharge, estim. <10 days

  47. Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)

    Measured: 30 days

  48. Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)

    Measured: six months

  49. Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)

    Measured: 12 months

  50. Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)

    Measured: 24 months

  51. Target vessel failure (TVF) rate (composite of cardiac death, MI and TVR)

    Measured: 36 months

  52. Change in Quality of Life

    Functional status of general health-related quality of life (QoL) measured by changes in SF-12 scores and EQ5D scores as compared to baseline

    Measured: six months

  53. Change in Quality of Life

    Functional status of general health-related quality of life (QoL) measured by changes in SF-12 scores and EQ5D scores as compared to baseline

    Measured: 12 months

  54. Change in Quality of Life

    Functional status of general health-related quality of life (QoL) measured by changes in SF-12 scores and EQ5D scores as compared to baseline

    Measured: 24 months

  55. Change in Quality of Life

    Functional status of general health-related quality of life (QoL) measured by changes in SF-12 scores and EQ5D scores as compared to baseline

    Measured: 36 months

Timeline

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

  1. First posted30 May 2014 (estimated)
  2. Study start13 Aug 2014
  3. Primary completion27 Apr 2017
  4. Study completion28 Oct 2019

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02151812
Sponsor's protocol ID
HTQ002-Agent-ISR
Other IDs
CIV-13-11-011728
Acronym
AGENT-ISR
Status last verified
Dec 2019
First submitted
28 May 2014
Last updated
23 Dec 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Hamm CW, Dorr O, Woehrle J, Krackhardt F, Ince H, Zeus T, Berland J, Piot C, Roubille F, Schult I, Allocco DJ, Nef H. A multicentre, randomised controlled clinical study of drug-coated balloons for the treatment of coronary in-stent restenosis. EuroIntervention. 2020 Jul 17;16(4):e328-e334. doi: 10.4244/EIJ-D-19-00051.

    PubMed 31746743

Questions about this trial

What is this clinical trial studying?

A study testing Agent Paclitaxel-coated balloon and SeQuent® Please Paclitaxel-coated Balloon in people with Coronary Artery Disease and Coronary Restenosis, run by Hemoteq AG at 12 sites in 2 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 11 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 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Germany, France. 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.

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-stent late lumen loss (time frame: six 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 NCT02151812, 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 23 Dec 2019.

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