BIOLUX P-I First in Man Study

Status Completed

Clinical Trial Summary

A prospective, multi-centre, randomized controlled, First in Man study to assess the safety and performance of the coated Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter vs. an uncoated balloon catheter in patients with stenosis and occlusion of the femoropopliteal arteries.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01221610
Study type	Interventional
Source	Biotronik AG
Contact
Status	Completed
Phase	N/A
Start date	October 2010
Completion date	January 2013

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05052918` - The Effect of Exercise and Metformin on Carotid Intima-media Thickness in Patients With Prediabetes	N/A
Recruiting	`NCT04511234` - Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease	N/A
Completed	`NCT05906797` - Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis.	N/A
Completed	`NCT03273972` - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers	N/A
Suspended	`NCT02932176` - Machine Learning for Handheld Vascular Studies
Recruiting	`NCT05158257` - Clinical Of Plain Balloon Dilatation Combined Stent Versus Endovascular Debulking Combined Drug-coated Balloon to Treat Arteriosclerosis Occlusive Disease of Lower Extremity	N/A
Completed	`NCT01212900` - Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression	Phase 4
Completed	`NCT03697382` - Effect of Daily Steps on Fat Metabolism	N/A
Recruiting	`NCT06230406` - T-Mem GEne in Atherosclerosis
Completed	`NCT03654313` - Single and Multiple Ascending Doses of MEDI6570 in Subjects With Type 2 Diabetes Mellitus	Phase 1
Completed	`NCT00382564` - Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease	N/A
Recruiting	`NCT02894931` - Effects of Dietary Interventions on Serum and Macrophage Atherogenicity	N/A
Not yet recruiting	`NCT02578355` - National Plaque Registry and Database	N/A
Completed	`NCT02998918` - Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL	N/A
Recruiting	`NCT02265250` - Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
Completed	`NCT02224339` - New Technologies to Determine Carotid Plaque Vulnerability
Completed	`NCT03393377` - Preventive Arterial Wall Phenotype and Low-dose Fluvastatin/Valsartan Combination	N/A
Completed	`NCT02268513` - Mediators of Atherosclerosis in South Asians Living in America (MASALA) Social Network Study
Not yet recruiting	`NCT01923012` - Phase II Randomized Placebo-controlled Study With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis	Phase 2
Completed	`NCT02377310` - Pd/Pa vs iFR™ in an Unselected Population Referred for Invasive Angiography	N/A