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

NCT ID: NCT01651390

Last Updated: 2016-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 231 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2016-07-31

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.

Detailed Description

This clinical investigation is an international, multi-center, randomized controlled trial with angiographic follow up at 6 months. Clinical follow ups will take place at 6, 12 and 18 months.

Up to 210 subjects will be block randomized 2:1 to receive the Pantera Lux balloon or the Orsiro stent and will be stratified according to diabetic status at screening.

Conditions

Coronary Artery Disease; Coronary Restenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug coated balloon

Percutaneous coronary intervention with the Pantera Lux drug coated balloon.

Group Type: EXPERIMENTAL

Percutaneous coronary intervention

Intervention Type: 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.

Drug eluting stent

Percutaneous coronary intervention with the Orsiro drug eluting stent.

Group Type: ACTIVE_COMPARATOR

Percutaneous coronary intervention

Intervention Type: DEVICE

Up to 70 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 Orsiro drug eluting stent.

Interventions

Percutaneous coronary intervention

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.

Intervention Type: DEVICE

Percutaneous coronary intervention

Up to 70 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 Orsiro drug eluting stent.

Intervention Type: DEVICE

Other Intervention Names

Pantera Lux drug coated balloon; Paclitaxel; BTHC (Butyryltri-n-hexyl Citrate); Orsiro drug eluting stent; Orsiro hybrid drug eluting stent system; Sirolimus eluting stent

Eligibility Criteria

Inclusion Criteria

1. Subject has provided a written informed consent

2. Subject ≥ 18 years

3. Clinical evidence of ischemic heart disease and/or a positive functional study, stable or unstable angina pectoris or documented silent ischemia

4. Subject eligible for percutaneous coronary intervention

5. Subject acceptable candidate for coronary artery bypass surgery

6. 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

7. 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.

8. Target reference vessel diameter (visual estimation): ≥ 2.0 and ≤ 4.0 mm

9. Target lesion length (visual estimation): ≥ 6.0 and ≤ 28.0 mm

10. Target lesion stenosis (visual estimation): > 50 % and ≤ 100 %

11. Target lesion in a native coronary artery

Exclusion Criteria

1. 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.

2. Evidence of acute ST-segment-elevation myocardial infarction within 48 hours prior to index procedure according to the universal definition of myocardial infarction

3. Subjects with acute cardiac decompensation or acute cardiogenic shock

4. Subject with a life expectancy of less than 18 month

5. In the investigators opinion subject who will not be able to comply with the follow up requirements

6. 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)

7. Thrombus in the target vessel

8. Target lesion located in left main coronary artery

9. Documented left ventricular ejection fraction (LVEF) ≤ 30%

10. 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

11. 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)

12. Subject currently enrolled in other investigational device or drug trial in which primary endpoint has not been reached

13. Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study

14. Previously enrolled in this trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph K Naber, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Universitäts-Herzzentrum Freiburg-Bad Krozingen

Bad Krozingen, , Germany

Heart Center Segeberger Kliniken

Bad Segeberg, , Germany

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

Berlin, , Germany

Innere Medizin Kardiologie - Charité Centrum 11, Campus Benjamin Franklin

Berlin, , Germany

Kardiologie - Angiologie - Pneumologie, Klinikum Coburg

Coburg, , Germany

Contilia Heart- and Vascular Center, Elisabeth Krankenhaus

Essen, , Germany

Medical Care Center Prof. Mathey, Prof. Schofer

Hamburg, , Germany

Kardiologie /Intern. Intensivmedizin, Johannes Wesling Klinikum Minden

Minden, , Germany

Klinikum Schwabing

Munich, , Germany

LMU - Klinikum der Universität München

Munich, , Germany

Klinikum Bogenhausen

Munich, , Germany

Universitätsklinikum Münster, Klinik für Kardiologie

Münster, , Germany

Innere Medizin III Kardiologie, Kliniken Villingen

Villingen-Schwenningen, , Germany

Cardiology, Pauls Stradins Clinical University Hospital

Riga, , Latvia

Countries

Germany; Latvia

References

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.

Reference Type: BACKGROUND

PMID: 17470709 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10545431 (View on PubMed)

Other Identifiers

C1105

Identifier Type: -

Identifier Source: org_study_id