Clinical Trials

The Clinical Trials and Research Studies are a part of the work carried out by iVascular.
The Clinical Trials studies that test how well new medical approaches work in people.

EFFPAC – EFFectiveness of PAClitaxel coated balloon luminor 35

Device: luminor 35 (Paclitaxel-coated balloon)

Description: Phase III Multicenter Randomized Controlled Trial to Assess the Effectiveness of Paclitaxel-coated Luminor® Balloon Catheter versus Uncoated Balloon Catheter in the Superficial Femoral and Popliteal Arteries to Prevent Vessel Restenosis or Reocclusion

Patients: Prospective 172

Primary endpoint: Late lumen loss (LLL) at 6 months

Secondary endpoints: Occurrence of restenosis defined as incidence of restenosis ≥50%, Freedom from Target lesion / vessel revascularization (TLR and TVR), Rutherford stage @ 6M and 12M, Ankle‐brachial index (ABI) @ 6M and 12M, Walking distance to baseline @ 6M and 12M, “Quality of Life” according to the WiQ and EQ5D @ 6M and 12M

Participants: Prof. U. Teichgräber (PI) – Universitätsklinikum Jena; Prof. D. Scheinert – Universitätsklinikum Leipzig; Prof. T. Zeller – Herzzentrum Bad Krozingen; Dr. med. S. Sixt – Angiologikum GmbH; PD Dr. med. M. Treitl – Universitätsklinikum München; Prof. Dr. med. S. Duda – Ihre-Radiologen;  Dr. med. M. Thieme – Medinos Kliniken Sonneberg; Prof. Dr. E. Blessing – SRH Karlsbad-Langensteinbach; PD Dr. H. Krankenberg – Herz und Gefäßzentrum Bad Bevensen; Prof. Dr. K. Brechtel – Ihre Radiologen Berlin Gemeinschaftspraxis; Dr. Michael Lichtenberg – Klinikum Arnsberg; Dr. Peter von Flotow – Westpfalz-Klinikum GmbH Standort II Kusel

 

EVOLUTION – Physician-initiated trial investigating the Efficacy of the Self-expanding iVOLUTION nitinol stent for treatment of femoropopliteal lesions

Device: iVolution (Self-expandable nitinol stent)

Description: The objective of this clinical investigation is to evaluate the short-term (up to 12 months) outcome of treatment by means of the self-expanding iVolution nitinol stent in symptomatic (Rutherford 2-4) femoropopliteal arterial stenotic or occlusive lesions.

Patients: Prospective 100

Primary endpoint: Primary patency at 12 months

Secondary endpoints: Primary patency at 1 & 6 months, Technical Success, freedom from Target Lesion Revascularization (TLR) at 1, 6 & 12 months, Clinical Success at 1, 6 & 12 months, MACE.

Participants: Dr. Bosiers (PI), Dr. Deloose – A.Z. Sint-Blasius (Dendermonde, BEL); Dr. Peeters – Imelda Hospital (Bonheiden, BEL); R.Z. Heiling-Hart (Tienen, BEL); Dr. Maene – OLV Hospital (Aalst, BEL)

 

ANCHOR – Percutaneous Coronary Intervention with the ANgiolite Drug-Eluting Stent: an Optical CoHerence TOmogRaphy Study.

Device: angiolite (Sirolimus eluting stent)

Description: To perform a first-in-man assessment of feasibility, exploratory efficacy and clinical performance of the novel angiolite drug-eluting stent utilizing intracoronary optical coherence tomography (OCT)

Patients: Prospective 100

Primary endpoint: 6-month neointimal coverage (n=50 patients), 6-month neointimal obstruction (n=50 patients)

Secondary endpoints: 3-month neointimal coverage (n=25 patients), 3-month neointimal obstruction (n=25 patients), 3 and 6-month malapposition rate (OCT strut level analysis) (n=75 patients), 6-month in-stent angiographic late lumen loss (QCA analysis), 6-month in-stent and in-segment restenosis (QCA analysis), 6-month and 1-year major adverse cardiac events (MACE) (CV death, MI, clinical target lesion revascularization (TLR), stent thrombosis)

Participants: Dr. Josep Rodés-Cabau (PI) – Quebec Heart and Lung Institute (Quebec City, CAN); Dr. Bruno García – Hospital Vall d’Hebron (Barcelona, SPA); Dr José María de la Torre – Hospital Universitario Marqués de Valdecilla (Santander, SPA); Dr. Luís Nombela – Hospital Clínica San Carlos (Madrid, SPA); Dr. Manel Sabaté – Hospital Clínic (Barcelona, SPA); Dr. Armando Perez de Prado – Hospital Universitario de León (León, SPA)

*Puri R, Otaegui I, Sabate M, et al. Three- and 6-month optical coherence tomographic surveillance following percutaneous coronary intervention with the Angiolite® drug-eluting stent: The ANCHOR study. Catheter Cardiovasc Interv. 2017;00:000–000. https://doi.org/10.1002/ccd.27189

 

LUMINOR registry

Device: lumnior 14 & luminor 35 (Paclitaxel coated balloons)

Description: Registry of the results of angioplasty with Drug-eluting Balloon (paclitaxel) in the treatment of infrainguinal occlusive lesions (superficial femoral artery (SFA), popliteal artery (PA) and tibial arteries (ATs)) and restenosis from prior endovascular procedures in this sector

Patients: prospective 250

Primary endpoint: A. Primary patency (performance target) of the angioplasty (PTA) performed with drug eluting balloons (DEB) in stenotic/occlusive primary lesions, in restenosis of the AFS, AP and ATs, or in stents from previous procedures in these arteries, with follow-up of 12 months. B. Freedom of adverse effects (AE). EA are considered in combination: death, amputation and the need for revascularization of the target lesion (safety objective).

Secondary endpoints: other valuation parameters that measure clinical and hemodynamic efficacy of the ATP performed with the DEB “LUMINOR”, as lack of complications and impact on quality of life

Participants: Dr. Francisco Acín – Hospital Universitario de Getafe (Madrid, SPA), Dr. Luis Riera del Moral – Hospital La Paz (Madrid, SPA), Dr. Manuel Alonso – Hospital Universitario Central de Asturias (Oviedo, SPA), Dr. Nilo Mosquera Arochena – University Hospital of Ourense (Ourense, SPA), Dr. Francisco Medina – University Hospital of Burgos (Burgos, SPA), Dr. Reyes Vega
– Hospital of Basurto (Bilbao, SPA), Dr. Mariano de Blas – Hospital de Donostia (Donosti, SPA), Dr. Juan Luis Fonseca Legrand – Hospital Cruces (Barakaldo, SPA), Dr. Antonio Giménez-Gaibar – Hospital Parc Taulí (Sabadell, SPA) and Dr. Vicente Riambau – Hospital Clínic (Barcelona, SPA).

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