Clinical Performance of the Pantera Lux Balloon Versus the Orsiro Stent in Patients With In-stent Restenosis.

NCT01651390 | Completed DMC

• 1 other identifier: C1105
• Study Type: interventional
• Target: 231
• Locations: 2 countries
• Sites: 14

Brief Summary

To determine in a randomized controlled trial (RCT) whether percutaneous coronary intervention - in patients with in-stent restenosis in either bare metal stents or drug eluting stents - with the Pantera Lux balloon is angiographically non-inferior to percutaneous intervention with the Orsiro stent 6 months post-procedure.

Conditions

Coronary Artery Disease; Coronary Restenosis

Keywords

Restenosis; Drug coated balloon; Drug eluting stent; Paclitaxel; Sirolimus

Outcome Measures

Primary Outcomes (1)

• Late lumen loss (in-stent)

  In-stent late lumen loss is defined as the difference between minimal luminal diameter after procedure and at 6 months, as evaluated by offline quantitative coronary angiography (QCA). In-stent: Pantera Lux balloon: In-stent is defined as from (proximal) shoulder to (distal) shoulder of the dilated balloon. Orsiro stent: In-stent is defined as from (proximal) edge to (distal) edge of the implanted Orsiro stent.

  After 6 months.

Secondary Outcomes (9)

• Percent diameter stenosis in-stent and in-segment

  After 6 months.

• Binary restenosis in-stent and in-segment

  After 6 months.

• Mean lumen diameter in-stent and in-segment

  After 6 months.

• Type of reoccurrence according to Mehran classification

  After 6, 12 and 18 months.

• Target lesion failure (TLF)

  After 6 and 18 months.

Study Arms (2)

Drug coated balloon

EXPERIMENTAL

Percutaneous coronary intervention with the Pantera Lux drug coated balloon.

Device: Percutaneous coronary intervention

Drug eluting stent

ACTIVE COMPARATOR

Percutaneous coronary intervention with the Orsiro drug eluting stent.

Device: Percutaneous coronary intervention

Interventions

Percutaneous coronary intervention DEVICE

Up to 140 patients meeting the inclusion criteria and none of the exclusion criteria are randomly selected and stratified according to diabetic status at screening are treated with the Pantera Lux drug coated balloon.

Also known as: Pantera Lux drug coated balloon, Paclitaxel, BTHC (Butyryltri-n-hexyl Citrate)

Drug coated balloon

Eligibility Criteria

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

You may qualify if:

• Subject has provided a written informed consent
• Subject ≥ 18 years
• Clinical evidence of ischemic heart disease and/or a positive functional study, stable or unstable angina pectoris or documented silent ischemia
• Subject eligible for percutaneous coronary intervention
• Subject acceptable candidate for coronary artery bypass surgery
• Subject with an in-stent restenotic lesion\* in either a bare metal stent or drug eluting stents (Mehran class I, II, III, IV - Mehran et al. Circulation 199; 100: 1872-1878). \*Target lesion
• Subjects with a maximum of 2 target lesions. In case of 2 target lesions, both lesions must be either in bare metal stents or drug eluting stents, and must treated during the same session with the same type of device as per randomization outcome, e.g. drug eluting stent.
• Target reference vessel diameter (visual estimation): ≥ 2.0 and ≤ 4.0 mm
• Target lesion length (visual estimation): ≥ 6.0 and ≤ 28.0 mm
• Target lesion stenosis (visual estimation): \> 50 % and ≤ 100 %
• Target lesion in a native coronary artery

You may not qualify if:

• Planned (staged) interventional treatment in the same vessel(s) as the target lesion(s) within 30 days pre- and/or post BIOLUX RCT index procedure.
• Evidence of acute ST-segment-elevation myocardial infarction within 48 hours prior to index procedure according to the universal definition of myocardial infarction
• Subjects with acute cardiac decompensation or acute cardiogenic shock
• Subject with a life expectancy of less than 18 month
• In the investigators opinion subject who will not be able to comply with the follow up requirements
• Impaired renal function (excluded are subjects in need of dialysis or subjects with a creatinine level ≥ 221 µmol per liter (2.5 mg per deciliter) within 72 hours of the intended treatment)
• Thrombus in the target vessel
• Target lesion located in left main coronary artery
• Documented left ventricular ejection fraction (LVEF) ≤ 30%
• Known allergies to: acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor, heparin, contrast medium, sirolimus or similar drugs (i.e., ABT 578, biolimus, tacrolimus); CoCr, PLLA, silicon carbide
• Subject is receiving oral or intravenous immunosuppressive therapy (e.g., inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
• Subject currently enrolled in other investigational device or drug trial in which primary endpoint has not been reached
• Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study
• Previously enrolled in this trial

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (14)

Universitäts-Herzzentrum Freiburg-Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Heart Center Segeberger Kliniken

Bad Segeberg, 23795, Germany

Location

Charité - Universitätsmedizin Berlin, Charité Centrum 11 für Herz-, Kreislauf- und Gefäßmedizin

Berlin, 10117, Germany

Location

Innere Medizin Kardiologie - Charité Centrum 11, Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Kardiologie - Angiologie - Pneumologie, Klinikum Coburg

Coburg, 96450, Germany

Location

Contilia Heart- and Vascular Center, Elisabeth Krankenhaus

Essen, 45138, Germany

Location

Medical Care Center Prof. Mathey, Prof. Schofer

Hamburg, 22527, Germany

Location

Kardiologie /Intern. Intensivmedizin, Johannes Wesling Klinikum Minden

Minden, 32429, Germany

Location

Klinikum Schwabing

Munich, 80804, Germany

Location

LMU - Klinikum der Universität München

Munich, 81337, Germany

Location

Klinikum Bogenhausen

Munich, 81925, Germany

Location

Universitätsklinikum Münster, Klinik für Kardiologie

Münster, 48149, Germany

Location

Innere Medizin III Kardiologie, Kliniken Villingen

Villingen-Schwenningen, 78050, Germany

Location

Cardiology, Pauls Stradins Clinical University Hospital

Riga, LV-1002, Latvia

Location

Related Publications (2)

• Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313.

  PMID: 17470709 BACKGROUND

• Mehran R, Dangas G, Abizaid AS, Mintz GS, Lansky AJ, Satler LF, Pichard AD, Kent KM, Stone GW, Leon MB. Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation. 1999 Nov 2;100(18):1872-8. doi: 10.1161/01.cir.100.18.1872.

  PMID: 10545431 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Restenosis

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Coronary Stenosis

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Christoph K Naber, MD

  Contilia Heart- and Vascular Center, Elisabeth Krankenhaus, Klara-Kopp-Weg 1, 45138 Essen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: July 27, 2012
• Study Start: June 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: July 1, 2016
• Last Updated: September 26, 2016

Record last verified: 2016-09

Locations

LA (1); DE (13)