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

NCT00998439 | Unknown Phase 2

• 1 other identifier: PEPCAD DES
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 8

Brief 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. 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.

Conditions

In-Stent Restenosis

Keywords

in stent restenosis; paclitaxel coated balloon catheter; pepcad; drug eluting balloon

Outcome Measures

Primary Outcomes (1)

• Late lumen loss

  6 months

Secondary Outcomes (14)

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

  3 years

• Major adverse cardiac event (MACE) rate

  30 days

• Percent in-stent stenosis

  6 months

• Percent in-segment stenosis

  6 months

• In-stent late loss index

  6 months

Study Arms (2)

Paclitaxel coated balloon catheter

EXPERIMENTAL

Device: SeQuent® Please

uncoated balloon catheter (POBA)

ACTIVE COMPARATOR

Device: SeQuent® II

Interventions

SeQuent® Please DEVICE

* 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

Also known as: paclitaxel coated balloon catheter, DEB

Paclitaxel coated balloon catheter

SeQuent® II DEVICE

* 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

Also known as: uncoated balloon catheter

uncoated balloon catheter (POBA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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))

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Klinikum Coburg: lead

Study Sites (8)

Zentralklinik Bad Berka GmbH

Bad Berka, D-99437, Germany

Location

Klinikum Bayreuth

Bayreuth, D-95445, Germany

Location

Klinikum Coburg

Coburg, D-96450, Germany

Location

Klinikum Kulmbach

Kulmbach, D-95326, Germany

Location

Herzzentrum Leipzig

Leipzig, D-04289, Germany

Location

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, D-23538, Germany

Location

LMU - Klinikum der Universität München

Munich, D-80336, Germany

Location

Klinikum Weiden

Weiden, D-92637, Germany

Location

Related Publications (3)

• 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.

  PMID: 26893095 DERIVED

• 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.

  PMID: 26476609 DERIVED

• 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.

  PMID: 22386286 DERIVED

Study Officials

• Harald Rittger, MD

  Klinikum Coburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: October 20, 2009
• Study Start: October 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 20, 2011

Record last verified: 2011-05

Locations

DE (8)