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In-Stent RestenosisPhase 2NCT00998439

Treatment of Drug-eluting Stent (DES) In-Stent Restenosis With SeQuent® Please Paclitaxel Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

A Phase 2 study testing SeQuent® Please and SeQuent® II in people with In-Stent Restenosis, run by Klinikum Coburg at 8 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of the study is to assess the efficacy of the Paclitaxel-eluting PTCA - balloon catheter SeQuent® Please to treat in-stent restenoses (ISR) of various drug eluting stents in native coronary arteries with reference diameters between 2.5 mm and ≤ 3.5 mm and lesion lengths ≤ 22 mm. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
In-Stent Restenosis
What is being tested?
SeQuent® Please and SeQuent® II
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
8 sitesGermany
Study dates
Oct 2009to Dec 2011
Phase
Phase 2
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 stable angina pectoris (CCS class 1-3) or with unstable angina pectoris (Braunwald class 1-2, A-C) or documented ischemia or with documented silent ischemia
  • Patients eligible for coronary revascularization by means of PCI
  • Patients suitable for coronary revascularization of any sort (balloon angioplasty, device-assisted balloon-angioplasty, or coronary artery bypass grafting)
  • Patients must be ≥ 18 years of age
  • Women of childbearing potential may not be pregnant nor have the desire to becoming pregnant during the first year following the study procedure. Hence, patients will be advised to use an adequate birth control method up to and including 6 months follow-up
  • Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol
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  • Patients must agree to undergo the 6 months angiographic follow-up
  • Patients must agree to undergo the 1 and 3 year clinical follow-up
  • Patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial, e.g., balloon angioplasty by means of the paclitaxel-eluting PTCA-balloon catheter or other suitable devices. The patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document.
  • In-stent restenosis or Mehran type III stenoses reaching ≤ 2 mm into the adjacent native vessel of a drug eluting stent (DES), in a native coronary artery (reference vessel between ≥ 2.5 and ≤ 3.5 mm, lesion length ≤ 22 mm as angiographically documented)
  • Diameter stenosis pre procedure must be either ≥ 70 % or ≥ 50 % if ischemia corresponding to the target lesion is documented either by exercise stress ECG, stress echocardiography, scintigraphy, MRT, or suspected based on angina pectoris.
  • DES in-stent restenosis independent of the the number of metal layers (e.g. restenosed DES following BMS and/or DES implantation(s))

Who cannot join

  • Patients with acute (< 24 h) or recent (48 hours) myocardial infarction
  • Patients with unstable angina pectoris (Braunwald class 3)
  • Patients with severe congestive heart failure
  • Patients with severe heart failure NYHA IV
  • Patients demonstrating clinical signs of cardiogenic shock at the time of the procedure (systolic blood pressure of less than 80 mmHg requiring inotropic support, IABP and/or fluid challenge)
  • Patients with severe valvular heart disease
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  • Women who are pregnant or lactating patients with life expectancy of less than five years or factors making clinical follow-up difficult
  • Patients with another coronary stent previously implanted into the target vessel
  • Patients with bleeding diathesis in whom anticoagulation or anti-platelet medication is contraindicated
  • Patients who had a cerebral stroke < 6 months prior to the procedure
  • Patient participates in other clinical trials involving any investigational device or drug
  • Untreated hyperthyroidism
  • Patient has presence or history of severe renal failure (GFR < 30ml/min) and is therefore not eligible for angiography. Patient's serum creatinine levels must be documented.
  • Post transplantation of any organ or immune suppressive medication
  • Other disease to jeopardize follow-up (e.g. malignoma)
  • Addiction to any drug or to alcohol
  • Patients with any type of surgery during the week preceding the interventional procedure
  • Conditions which prevent the intake of the double anti-platelet therapy for three months
  • Evidence of extensive thrombosis within target vessel before the intervention
  • Side branch > 2 mm in diameter originating from the stent
  • Bifurcate lesion
  • Left main coronary artery stenosis
  • Multilesion percutaneous coronary intervention within the same artery (a main artery e.g., LCX and its side branch e.g. OMS are considered as different arteries)
  • Percutaneous coronary intervention of venous graft
  • Coronary artery occlusions of any type (e.g. acute or chronic)
  • In-segment stenosis of the native vessel within the 5 mm adjacent to the stent
  • Lesion within 1 mm of vessel origin
  • Patient is intolerant to aspirin and/or the ADP-antagonists clopidogrel or has a history of neutropenia, thrombocytopenia induced by ADP-antagonists, or severe hepatic dysfunction prohibiting the use of clopidogrel
  • Patient has leucopoenia (leukocyte count < 109/liter for more than 3 days)
  • Patient has neutropenia (ANC < 1000 neutrophils/mm3 for more than 3 days)
  • Patient has a history of peptic ulcer or gastric/intestinal bleeding during the past 6 months
  • Patient has a history of thrombocytopenia (< 100,000 platelets/mm3)

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Germany8 sites

  • Zentralklinik Bad Berka GmbH

    Bad Berka, D-99437

  • Klinikum Bayreuth

    Bayreuth, D-95445

  • Klinikum Coburg

    Coburg, D-96450

  • Klinikum Kulmbach

    Kulmbach, D-95326

  • Herzzentrum Leipzig

    Leipzig, D-04289

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck

    Lübeck, D-23538

  • LMU - Klinikum der Universität München

    Munich, D-80336

  • Klinikum Weiden

    Weiden, D-92637

Other trials in Germany

About this study

Official title: PEPCAD DES - Treatment of DES-In-Stent Restenosis With SeQuent® Please Paclitaxel Eluting PTCA Catheter

The aim of the study is to assess the efficacy of the Paclitaxel-eluting PTCA - balloon catheter SeQuent® Please to treat in-stent restenoses (ISR) of various drug eluting stents in native coronary arteries with reference diameters between 2.5 mm and ≤ 3.5 mm and lesion lengths ≤ 22 mm. The vessel patency following treatment with SeQuent® Please will be documented in ISR patients that have been treated with the Cypher® or Taxus® drug eluting stent.

Read the detailed description

Background information

Current treatments for In Stent Restenosis (ISR) are 'uncoated balloon only' angioplasty with conventional balloons (POBA), Bare Metal Stent (BMS) implantations, cutting balloons, rotablation and atherectomy. Their respective results to lower target vessel revascularizations were in part unsatisfactory and often conflicting. Also the temporary use of brachytherapy lead to late lumen loss (LLL) findings in the range from 0.22 ± 0.84 mm. Therefore, brachytherapy to treat ISR has also been abandoned because of the associated delayed endothelialization leading to late thrombosis.

The use of drug eluting stents (DES) to treat ISR lowered restenosis rates in the single digit range. Recently, the use of matrix coated paclitaxel-eluting PTCA balloon catheters (SeQuent® Please, Paccocath Technology®, Bayer/Schering \& B.Braun Melsungen AG) was compared to PES in the PEPCAD II trial which showed significantly lower 6-month LLL, 6-month MACE and TVR rates for SeQuent® Please (7.25%) as compared to PES for which the 12-month TVR rate was 19.0% and therefore in agreement with prior studies (ISAR DESIRE). Since these assessments were done in patients with BMS in-stent restenosis, it is of paramount interest to study in-stent restenosis of failed DES implantations since they may cause continued chronic inflammatory responses caused by the non-bioabsorbable polymer in particular once the drug release has ceased.

Being tested
SeQuent® Please, SeQuent® II
Keywords
in stent restenosis, paclitaxel coated balloon catheter, pepcad, drug eluting balloon

What participants receive

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

  • SeQuent® PleaseDevice

    Also called paclitaxel coated balloon catheter, DEB

    • 6 F, 7 F, or 8 F guiding catheters have to be used
    • after insertion of arterial sheath, apply heparin (7,500-10,000 Units i.a. or i.c. (or 50-100 U/kg body weight))
    • additional dose of 5,000 Units (75 U/kg body weight) if procedure lasts for more than one hour
    • Nitroglycerin (0.2 mg i.c.) prior to first contrast injection
    • ISR must be predilated with uncoated balloon
    • balloon diameter shall be 0.5 mm smaller than the Paclitaxel-eluting balloon intended for use
    • inflation time has to be ≥ 30 sec
    • select balloon with correct stent diameter to achieve a remaining stenosis of ≤ 10 %
    • each Paclitaxel-eluting balloon catheter is allowed for single use only
    • additional inflations and/or aggressive anti-platelet agents for intraluminal defects or haziness
    • if additional balloon is necessary, only uncoated balloon is permitted to avoid overdosing of drug

  • SeQuent® IIDevice

    Also called uncoated balloon catheter

    • 6 F, 7 F, or 8 F guiding catheters have to be used
    • after insertion of arterial sheath, apply heparin (7,500-10,000 Units i.a. or i.c. (or 50-100 U/kg body weight))
    • additional dose of 5,000 Units (75 U/kg body weight) if procedure lasts for more than one hour
    • Nitroglycerin (0.2 mg i.c.) prior to first contrast injection
    • ISR must be predilated with uncoated balloon
    • balloon diameter shall be 0.5 mm smaller than the Paclitaxel-eluting balloon intended for use
    • inflation time has to be ≥ 30 sec
    • select balloon with correct stent diameter to achieve a remaining stenosis of ≤ 10 %
    • each Paclitaxel-eluting balloon catheter is allowed for single use only
    • additional inflations and/or aggressive anti-platelet agents for intraluminal defects or haziness
    • if additional balloon is necessary, only uncoated balloon is permitted to avoid overdosing of drug
Study groups in NCT00998439
Study groupRoleWhat they receive
Paclitaxel coated balloon catheterExperimentalNot described
Receives: Device: SeQuent® Please
uncoated balloon catheter (POBA)Active comparatorNot described
Receives: Device: SeQuent® II

What is being measured

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

  1. Late lumen loss

    Measured: 6 months

Secondary outcomes (14)

  1. Occurrence of acute (up to 48 hours), subacute (up to 30 days), and late thrombosis

    Measured: 3 years

  2. Major adverse cardiac event (MACE) rate

    Measured: 30 days

  3. Percent in-stent stenosis

    Measured: 6 months

  4. Percent in-segment stenosis

    Measured: 6 months

  5. In-stent late loss index

    Measured: 6 months

  6. Angiographic binary in-stent stenosis rate

    Measured: 6 months

  7. In-segment late loss index

    Measured: 6 months

  8. Angiographic binary in-segment stenosis rate

    Measured: 6 months

  9. Indication for premature follow-up

    Measured: 6 months

  10. Type of recurrence (Mehran-Classification)

    Measured: 6 months

  11. Target vessel failure

    Measured: 6 months

  12. MACE Rate

    Measured: 6 months

  13. MACE Rate

    Measured: 1 year

  14. MACE Rate

    Measured: 3 years

Timeline

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

  1. First posted20 Oct 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionSep 2011 (estimated)
  4. Study completionDec 2011 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00998439
Sponsor's protocol ID
PEPCAD DES
Status last verified
May 2011
First submitted
10 Sep 2009
Last updated
20 May 2011
Results posted
No
Data monitoring committee
No

Publications

  • Rittger H, Wohrle J, Brachmann J, Hohenforst-Schmidt W, Schlundt C, Lonke S, von Cranach M, Markovic S, Achenbach S, Waliszewski M. Angiographic patterns of drug-eluting stent restenosis after treatment with drug-coated balloon versus balloon angioplasty: Late lumen loss subgroup analyses of the PEPCAD-DES study. Catheter Cardiovasc Interv. 2016 Oct;88(4):529-534. doi: 10.1002/ccd.26451. Epub 2016 Feb 19.

    PubMed 26893095

  • Rittger H, Waliszewski M, Brachmann J, Hohenforst-Schmidt W, Ohlow M, Brugger A, Thiele H, Birkemeyer R, Kurowski V, Schlundt C, Zimmermann S, Lonke S, von Cranach M, Markovic S, Daniel WG, Achenbach S, Wohrle J. Long-Term Outcomes After Treatment With a Paclitaxel-Coated Balloon Versus Balloon Angioplasty: Insights From the PEPCAD-DES Study (Treatment of Drug-eluting Stent [DES] In-Stent Restenosis With SeQuent Please Paclitaxel-Coated Percutaneous Transluminal Coronary Angioplasty [PTCA] Catheter). JACC Cardiovasc Interv. 2015 Nov;8(13):1695-700. doi: 10.1016/j.jcin.2015.07.023.

    PubMed 26476609

  • Rittger H, Brachmann J, Sinha AM, Waliszewski M, Ohlow M, Brugger A, Thiele H, Birkemeyer R, Kurowski V, Breithardt OA, Schmidt M, Zimmermann S, Lonke S, von Cranach M, Nguyen TV, Daniel WG, Wohrle J. A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study. J Am Coll Cardiol. 2012 Apr 10;59(15):1377-82. doi: 10.1016/j.jacc.2012.01.015. Epub 2012 Feb 29.

    PubMed 22386286

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SeQuent® Please and SeQuent® II in people with In-Stent Restenosis, run by Klinikum Coburg at 8 sites in Germany.

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 12 inclusion and 32 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: status not confirmed, as of the sponsor's last update on 20 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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 lumen loss (time frame: 6 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 NCT00998439, which also lists 3 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 20 May 2011.

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